Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043047788

FEI Number

3043047788

Entity Name

ERGODENTA APS

City/State/Country

Taastrup Hovedstaden, DK

Establishment Address

Horskatten 14, Taastrup Hovedstaden 2630, DK

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ErgoDenta ApS (Owner Number: 10094892)

Owner / Operator Contact Address

Horskaetten 14, Taastrup, DK-NOTA 2630, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nordberg Molt 5mm-8mm Micro Surgery Periosteal Elevator, 2.5mm-4mm Miller 21, 3mm Freer, 5mm-5mm Prichard, 5mm-11mm Buser, 4mm-4mm All Round Surgery Kit Glickmann, 4mm-4mm Nordberg Molt 4mm-7mm Mini Glickman, 3mm-3mm Zucchelli 3mm-3mm Micro Surgery Kit Bone Scrapper, 3mm-5mm Micro Surgery Periosteal Elevator, 1.8mm-2.8mm Kramer-Nevins #1, 4mm-7mm Curettes #1, 4mm-4mm Kramer-Nevins #2, 4mm-7mm Sinus Lift Instrument, 3mm-3mm Curettes #2, 3mm-4mm Sinus Lift Instrument, 4mm-4mm 209 - Pre molar rubberdam clamps 10 - Molar rubber dam clamps (GENERAL) 6 - Anterior Rubber Dam Clamps Rubber Dam Clamp Forceps Washington, 17cm 8A - Molar rubber dam clamps (GENERAL) 18 - Molar rubber dam clamps (GENERAL) 56S - Molar rubber dam clamps (GENERAL) W8 - Upper molar rubber dam clamps G27N - Pre molar rubberdam clamps K27N - Pre molar rubberdam clamps 212SA - Anterior Rubber Dam Clamps 8 - Upper molar rubber dam clamps 14 - Molar rubber dam clamps (GENERAL) 3 - Lower molar rubber dam clamps Ivory Rubber Dam Clamp Forceps, 17cm 7A - Lower molar rubber dam clamps 25 - Molar rubber dam clamps (GENERAL) 12A - Lower molar rubber dam clamps W8A - Molar rubber dam clamps (GENERAL) Ivory Rubber Dam Punch Forceps, 16cm 28 - Lower molar rubber dam clamps 30 - Upper molar rubber dam clamps 8AD - Molar rubber dam clamps (GENERAL) 11 - Molar rubber dam clamps (GENERAL) W14A-Molar rubber dam clamps (GENERAL) 2AS - Pre molar rubberdam clamps 4 - Upper molar rubber dam clamps Rubber Dam Clamp Forceps Stockes, 17cm 56 - Molar rubber dam clamps (GENERAL) G27 - Molar rubber dam clamps (GENERAL) Ainsworth Rubber Dam Punch, 17cm 205 - Upper molar rubber dam clamps W7 - Lower molar rubber dam clamps 26 - Lower molar rubber dam clamps W14 - Molar rubber dam clamps (GENERAL) 00 - Anterior Rubber Dam Clamps Rubber Dam Clamp Forceps Brewer, 17cm 9 - Anterior Rubber Dam Clamps 27 - Molar rubber dam clamps (GENERAL) 24 - Molar rubber dam clamps (GENERAL) W3 - Lower molar rubber dam clamps 13A - Lower molar rubber dam clamps 7 - Lower molar rubber dam clamps Rubber Dam Stand, 9cm x 10cm W12A - Lower molar rubber dam clamps 29 - Pre molar rubberdam clamps 26N - Upper molar rubber dam clamps 1A - Pre molar rubberdam clamps 27N - Pre molar rubberdam clamps W00 - Anterior Rubber Dam Clamps 201 - Upper molar rubber dam clamps 1 - Pre molar rubberdam clamps 2A - Pre molar rubberdam clamps 5 - Upper molar rubber dam clamps 212 - Anterior Rubber Dam Clamps 0 - Pre molar rubberdam clamps W4 - Upper molar rubber dam clamps 14A - Molar rubber dam clamps (GENERAL) 2 - Pre molar rubberdam clamps 31 - Upper molar rubber dam clamps W2 - Pre molar rubberdam clamps Rubber Dam Stand, 10cm x 11cm Ivory Rubber Dam Punch Forceps, Parts Rubber Dam Clamp Forceps White, 17cm 9S - Anterior Rubber Dam Clamps ErgoX Plus Mirror handle, Lemon Green Ortho 0-25 Mirror Handle, ErgoX, Misty Cyan HD Mouth Mirror, No. 5, 24mm , Blue ErgoX Plus Mirror handle, Peach Blush Plain Mouth Mirror, No. 5, 24mm Microscopic HD Mouth Mirror, 3mm, Black, Regular 1.5mm ErgoX Plus Mirror handle, Pure Black ErgoX Plus Mirror handle, Aqua Light HD Mouth Mirror, No. 4, 22mm, Blue ErgoX Mirror handle, Misty Cyan Microscopic HD Mouth Mirror, 2x7mm, Black, Regular 1.5mm ErgoLite Mirror handle, Ruby Pink ErgoX Mirror handle, Ruby Pink Front-Surface Mouth Mirror, No. 5, 24mm ErgoLite Mirror handle, Petal Pink ErgoX Plus Mirror handle, Citrus Orange ErgoX Mirror handle, Sky Cyan ErgoLite Mirror handle, Honey Brown ErgoLite Mirror handle, Magenta Blue Ortho 0-25 Mirror Handle, ErgoX Pro, Misty Cyan HD Mouth Mirror, No. 5, 24mm, Pink ErgoSteel Standard, Mirror handle ErgoX Plus Mirror handle, Sky Cyan Microscopic HD Mouth Mirror, 3mm, Black, UltraThin 0.7mm ErgoX Plus Mirror handle, Deep Blue ErgoLite Mirror handle, Sky Cyan ErgoX Mirror handle, Honey Brown ErgoX Plus Mirror handle, Magenta Blue ErgoSteel Plus, Mirror handle HD Mouth Mirror, No. 5, 24mm, Black ErgoX Plus Mirror handle, Misty Cyan ErgoX Plus Mirror handle, Earth Brown ErgoX Plus Mirror handle, Teal Deep ErgoX Mirror handle, Earth Brown ErgoLite Mirror handle, Lemon Green ErgoX Mirror handle, Petal Pink Microscopic HD Mouth Mirror, 3x9mm, Black, UltraThin 0.7mm HD Mouth Mirror, No. 4, 22mm, Black ErgoX Mirror handle, Citrus Orange Microscopic HD Mouth Mirror, 5mm, Black, Regular 1.5mm ErgoLite Mirror handle, Lilac Blue HD Mouth Mirror, No. 5, 24mm, Green HD Mouth Mirror, No. 4, 22mm, Green Plain Mouth Mirror, No. 3, 20mm Double End steel Handle, 8mm Microscopic HD Mouth Mirror, 2x7mm, Black, UltraThin 0.7mm Single End steel Handle, 8mm ErgoX Plus Mirror handle, Ruby Pink Front-Surface Mouth Mirror, No. 3, 20mm ErgoLite Mirror handle, Citrus Orange ErgoX Plus Mirror handle, Honey Brown ErgoLite Mirror handle, Pure Black Microscopic HD Mouth Mirror, 3x9mm, Black, Regular 1.5mm ErgoX Mirror handle, Pure Black Microscopic HD Mouth Mirror, 5mm, Black, UltraThin 0.7mm ErgoX Mirror handle, Teal Deep ErgoX Mirror handle, Aqua Light ErgoLite Mirror handle, Misty Cyan Front-Surface Mouth Mirror, No. 4, 22mm ErgoX Mirror handle, Deep Blue ErgoX Mirror handle, Lemon Green ErgoX Plus Mirror handle, Lilac Blue ErgoX Mirror handle, Peach Blush Microscopic HD Mouth Mirror, 7mm, Black, UltraThin 0.7mm HD Mouth Mirror, No. 4, 22mm, Pink ErgoSteel Mini, Mirror handle Plain Mouth Mirror, No. 4, 22mm ErgoX Mirror handle, Magenta Blue ErgoX Mirror handle, Lilac Blue ErgoX Plus Mirror handle, Petal Pink Action Excavator 2mm Action Excavator, 2mm Round Excavators 2.5mm Round Excavator, 2mm Round Excavator, 3mm Spoon Excavator, 1mm Spoon Excavator, 2.5mm Action Excavator 1mm Spoon Excavator, 2mm Spoon Excavator, 1.7mm Action Excavator, 1.5mm Action Excavator, 1mm Round Excavator 2mm Spoon Excavator, 1.3mm Round Excavator, 2.5mm Periotome Anterior, 2mm-3.4mm Round Excavator 1.5mm Round Excavator, 1mm Round Excavator 1mm Periotome 1, Curved / Straight, 2.2mm-2.2mm Round Excavator, 1.5mm Round Excavator, 1.7mm Periotome 2, Curved / Curved, 2.2mm-2.2mm Round Excavators 2mm Periotome Posterior, 1.4mm-1.4mm Spoon Excavator, 1.5mm Action Excavator 1.5mm Round Excavators 1.5mm Action Excavator, 3.5mm Gutta Percha Remover, Up-Down, 0.4mm Hook Crown Remover Plier Crown Remover with three tips Universal Crown Spreader Crown Removing Forceps, Curved, 17cm, TC Crown Scissor, Straight, 11.5cm Gutta Percha Remover, Left-Right, 0.4mm Hook Crown Scissor, BeeBee, Saw Edge, Straight, 13cm Universal Crown Scissor, Saw Edge, For wire cut, Angled, 12.5cm Lindblom crown Remover Plier Crown Tractor Plier, with spare 20 silicone pads Miller Crown Remover, with 4 tips Crown Spreader Plier, 15cm Crown Scissor, BeeBee, Saw Edge, Curved, 13cm Changeable parts for Crown Tractor Plier, 20 Spare silicone pads Universal cheek retractor Langenbeck Retractor, 60 x11 mm, 22cm Obwegeser Internal Retractor, 42 x 10 mm, 23cm Bowdler Henry Retractor, 16cm Sean-Miller Retractor, Middeldorpf Retractor, Small, 14 x 17 mm, 21cm Universal Cheek Retractor, 14cm S-retractor Obwegeser Internal Retractor, 32 x 10 mm, 23cm Langenbeck Retractor, 42 x11 mm, 22cm Obwegeser External Retractor, 70 x 14 mm, 23cm Obwegeser External Retractor, 40 x 11 mm, 23cm Sean-Miller Retractor, Sharp Wassmund Retractor, 30 x 20 mm, 22cm Middeldorpf Retractor, Medium, 20 x 22 mm, 21cm Cawood-Minnesota, 2x16cm, 15.5cm Obwegeser External Retractor, 31 x 10 mm, 23cm Periodontal Surgery Kit Obwegeser Internal Retractor, 55 x 12 mm, 23cm Langenbeck Retractor, 29 x 10 mm, 22cm Farabeuf Retractor, Set of 2 pcs, 12cm Fig. 1, 26 x 10 mm / 30 x 13 mm Fig. 2, 30 x 10 mm / 34 x 13 mm Wrench for ErgoTip Scalpel Handles No:3 Micro Surgery Kit Surgery kit Scalpel Handles No:3 180° All Round Surgery Kit Periodontal Surgery Kit Bone Spreader (set of 6 including hammer & cassette) Condenser Offset (Set of 7 including hammer & cassette) Condenser Straight (Set of 7 including hammer & cassette) Osteotome Offset (set of 5 including hammer & cassette) Osteotome Straight (set of 5 including hammer & cassette) Micro Surgical Tweezer, Straight, 18cm Stieglitz Forceps, Straight, 13cm Adson Forceps, Curved, 18cm Hartmann Forceps Straight, 10 CM Hartmann Forceps Curved, 10 CM Kelly Forceps, Straight All Round Surgery Kit Semken Tweezer, Straight, 12cm Micro Surgical Tweezer, Straight, 1-2, 15cm Rochester Pean Forceps, Curved, 16.5cm Adson Tweezer, 1-2, 12cm Adson Tweezer, Angled, 15cm Adson-1X2, 12 CM Semken Tweezer, Angled, 1-2, 15cm DeBakey Tweezer, Standard Profile 2mm, Straight16cm Halsted-Mosquito Forceps, Curved, 12cm Semken Tweezer, Curved, 15cm Micro Surgical Tweezer, Curved, 1-2, 18cm Adson Tweezer, 12cm, TC Adson Tweezer, 1-2, 15cm DeBakey Tweezer, Standard Profile 2mm, Angled, 16cm Micro Surgical Tweezer, Straight, 1-2, 18cm Anatomical Dressing Forceps, Standard Pattern, 14.5cm Gerald Tweezer, Straight, 1-2, 17cm Micro Mosquito Forceps, Straight, 10cm Halsted-Mosquito Forceps, Straight, 12cm Rochester Pean Forceps, Curved, 13.5cm Micro Mosquito Forceps, Straight, 12cm Adson Forceps, Straight, 14cm Tohoku Forceps, 10cm Crile Forceps, Straight, 14cm Stieglitz Forceps, Angled 45°, 13cm Kocher Forceps, Curved, 1-2, 13cm Micro Surgery Kit Micro Mosquito Forceps, Curved, 12cm Rochester Pean Forceps, Straight, 13.5cm Semken Tweezer, Curved, 12cm Crile Forceps, Curved, 14cm Semken Tweezer, Straight, 15cm Adson Forceps, Straight, 18cm Halsted-Mosquito Forceps, Straight, 14.5cm Kocher Forceps, Curved, 1-2, 16cm Semken Tweezer, Straight, 1-2, 15cm Adson Tweezer, 12cm Rochester Pean Forceps, Straight, 16.5cm Halsted-Mosquito Forceps, Curved, 14.5cm Anatomical Dressing Forceps, Standard Pattern, 16cm Gerald Tweezer, Curved, 1-2, 17cm Micro Surgical Plier 15 CM Adson 12 CM Anatomical Dressing Forceps, Standard Pattern, 13cm, TC Hartmann Forceps Angled (Crocodile) Periodontal Surgery Kit Allison Tissue Forceps, Straight, 15cm Micro Mosquito Forceps, Curved, 10cm Adson Tweezer, 15cm Kelly Forceps, Curved, 14cm Anatomical Dressing Forceps, Standard Pattern, 13cm Kocher Forceps, Straight, 1-2, 13cm Ergo X - ErgoTip handle, Orange ErgoTip Single End steel Handle, 8mm Ergo X - ErgoTip handle, Yellow Ergo X - ErgoTip handle, Red Ergo LX - ErgoTip handle, Single-end, Magenta Blue Ergo X - ErgoTip handle, Lemon Green Ergo X - ErgoTip handle, Grey Ergo LX - ErgoTip handle, Single-end, Aqua light ErgoTip Double End steel Handle, 8mm Ergo X - ErgoTip handle, Aqua light Ergo LX - ErgoTip handle, Single-end, Black Ergo X Plus - ErgoTip handle, Orange Ergo LX - ErgoTip handle, Single-end, Orange Ergo X - ErgoTip handle, Black Ergo X Plus - ErgoTip handle, Grey Ergo X Plus - ErgoTip handle, Black Ergo X Plus - ErgoTip handle, Lemon Green Ergo LX - ErgoTip handle, Single-end, Red Ergo X Plus - ErgoTip handle, Aqua light Ergo X Plus - ErgoTip handle, Yellow Ergo LX - ErgoTip handle, Single-end, Yellow Ergo X Plus - ErgoTip handle, Magenta Blue Ergo LX - ErgoTip handle, Single-end, Grey Ergo X Plus - ErgoTip handle, Red Ergo LX - ErgoTip handle, Single-end, Lemon Green Ergo X - ErgoTip handle, Magenta Blue Endo Spreader- 7S Endo Spreader 0.6mm & Plugger 0.8mm Endo Spreader 0.4mm & Plugger 0.6mm Endo Spreader- 1S Endo Spreader 0.6mm & Plugger 1mm Endo Spreader- 5S Endo Spreader- 4S Endo Spreader- 6S Endo Spreader- 3S Endo Spreader- 2S Endo Spreader 0.4mm & Plugger 0.4mm Bone Splitting instrument Straight 3mm Bone Splitting instrument Straight 8mm Bone Splitting instrument Curved 4mm Mallet) Solid Head Hammer 17cm 20mm Bone Splitting (Set of 8 including cassette) Solid Head 19cm 20mm Bone Splitting instrument Straight 4mm Bone Splitting instrument Curved 6mm Bone Splitting Straight and Straight Kit Bone Splitting instrument Curved 3mm Bone Splitting instrument Straight 6mm Teflone Hammer 18cm 26mm (Spare Jaws For Mead Bone Splitting instrument Curved 8mm Nystrom, Left, Coated Nystrom, Right Tofflemire, Junior Nystrom, Left Tofflemire, Universal Nystrom, Right, Coated Ivory, 5mm Tofflemire, Senior Bone Scrapper, 3mm-5mm Howard 67- Straight cut Tongue holder Howard 67 Tongue holder - Minnesota 2cm x 14cm Syringe holder Spencer Suture Scissor, Angled, 11.5cm Spencer Suture Scissor, Straight, 16cm Classic Suture Scissor, Straight, 13 cm. Classic Suture Scissor, Curved, 11.5cm Classic Suture Scissor, Curved, 13cm Classic Suture Scissor, Straight, 11.5 cm Angled Suture Scissor, Angled, 13cm. Razor Black Sickle Scaler H7 Sickle Scaler 204SD (A) M23A Mini Sickle 11-12 Razor Black Sickle Scaler 204S (B) Sickle Scaler H6 Razor Black Sickle Scaler M23 (B) Sickle Scaler 204S Sickle Scalers 204S Razor Black Sickle Scaler 204S (A) Hoe Scaler, Anterior Razor Gold Sickle Scaler H7 Micro Sickle 01-02 Razor Sickle Scaler 204SD (B) Razor Gold Sickle Scaler 204SD (A) Razor Sickle Scaler H7 Sickle Scaler 204S (B) Razor Gold Micro Sickle Scaler 01 Razor Mini Sickle Scaler 12 Razor Black Sickle Scaler 204SD (A) Hoe Scaler, Lateral Razor Black Mini Sickle Scaler 12 Razor Micro Sickle Scaler 01 Razor Gold Sickle Scaler 204SD (B) Micro Sickle Scaler 02 Sickle Scaler H6-H7 Nebraska 128 Razor Sickle Scaler M23 (A) Razor Gold Mini Sickle Scaler 11 Razor Sickle Scaler M23 (B) Razor Gold Mini Sickle Scaler 12 Mini Sickle Scaler 11 Crane-Kaplan Razor Gold Micro Sickle Scaler 02 Razor Sickle Scaler H6 Razor Gold Sickle Scaler M23 (A) Razor Gold Sickle Scaler M23 (B) Sharp Jack Scaler Razor Black Mini Sickle Scaler 11 Razor Gold Sickle Scaler 204S (B) Razor Black Sickle Scaler 204SD (B) Razor Gold Sickle Scaler H6 Razor Black Micro Sickle Scaler 02 Hoe Scaler, Posterior Sickle Scaler M23 Razor Gold Sickle Scaler 204S (A) Razor Black Micro Sickle Scaler 01 Sickle Scaler H7 Mini Excess Scaler Razor Black Sickle Scaler H6 Sickle Scaler 204SD Sickle Scaler 204S (A) Sickle Scaler 204SD (B) Razor Sickle Scaler 204S (B) Razor Mini Sickle Scaler 11 Razor Sickle Scaler 204SD (A) Razor Sickle Scaler 204S (A) Razor Micro Sickle Scaler 02 Razor Black Sickle Scaler M23 (A) Sickle Scalers 204SD Mini Sickle Scaler 12 Mini Sickle Scaler Sickle Scaler M23 (B) Sickle Scaler M23 (A) Micro Sickle Scaler 01 Furcator Scaler Micro Sickle Scaler M23 Explorer 2A Probe WHO 11.5mm (Ball End) Probe CP 2 Explorer 5-9 Probe CP 11 Explorer 9 Probe CP 2 (2-4-6-8-10-12mm) Nabers Probes (ball-end) Nabers Probe Probe CP 18 Explorer 5-8 Explorer 29 Explorer 5 WHO Probe Weston Explorer WHO Probe 11.5mm Probe CP 11 (3-6-8-11mm) Explorer 3A Probe 2 William Probe 2-4-6-8-10mm Probe 12 Probe 18 Explorer 17 Probe 2B Probe 15 Explorer 33 William Probe 3-5-8-11mm Furcation Probe William Probe Probe CP 2B (Ball-end) (2-4-6-8-10-12mm) Probe 12B Explorer 8 Probe CP 12B (Ball-end) CP Probe 15 (1-15mm) Probe CP 12 (3-6-9-12mm) Explorer-Holst Probe 11 Explorer 17C-23 Explorer 23 Explorer 17-9 Fig. 67A. Upper Molars Fig. 13. Lower Cuspids Fig. 7, Lower Roots Lower Molar Fig. 38 Incisors & Canins, Lower Jaw Lower Anterior Fig. 23. Lower Molars, Right Fig. 79. Lower Wisdom Teeths Fig. 86. Lower Molars Fig. 1. Upper Incisors And Molars Fig. 3 Upper Molar Upper Jaw-Molars Universal-Lower Roots Fig. 24. Lower Molars, Left Lower Spade Root Fig. 46. Upper Roots Fig. 22. Lower Molars Child extraction forceps kit, 7pcs Fig. 51S, Upper Roots Fig. 29. Upper Front Fig. 86A. Lower Upper Anterior Fig. 13K Premolars, Lower Jaw Fig. 6, Lower Molar Fig. 86B. Lower Child Diamond extraction forceps Kit, 7pcs Fig. 97. Upper Roots Fig. 18. Upper Molars, Left Fig. 87. Lower Fig. 5, Lower Incisiver Diamond extraction forceps Kit, 10pcs Fig. 74. Lower Roots Fig. 22K Molars, Lower Jaw Fig. 33A. Lower Incisors Upper Universal Fig. 139, Upper Pre Molar Fig. 7. Upper Premolars Fig. 144. Upper Roots Fig. 86A. Lower Molars Fig. 137, Upper Incisor Upper Molar Fig. 41. Upper Roots Lower Universal Fig. 99. Hertz (Lower Molars) Fig. 98. Witzel (Upper roots) Fig. 37 Incisors, Upper Jaw Standard extraction forceps Kit, 10pcs Universal-Upper Roots Fig. 30S. Upper Front Fig. 17. Upper Molars, Right Upper Spade Root Metzenbaum Fino Scissor, Curved, 14.5cm, TC Noyes Scissor, Straight, 15cm Metzenbaum Sharp Scissor, Straight, 14.5cm, TC Goldman Fox, Curved, 13 cm, Super-cut Mayo Scissor, Straight, 14.5cm, TC Mayo Scissor, Curved, 18cm, TC Goldman Fox, Straight, 13 CM, Super-cut All Round Surgery Kit Micro Surgery Kit Goldman Fox, Straight, 13cm, TC Metzenbaum Open Scissor, Straight, 14.5cm, TC Microsurgical Scissor, Curved, 14.5cm,TC Barraquer/Gingiva Scissor, Straight, 13cm, TC Mayo Scissor, Curved, 18cm Metzenbaum Stump Scissor, Straight, 14.5cm, TC Goldman Fox, Curved, 13cm, TC Goldman Fox, Curved, 13 cm, Black, Super-cut, TC Kilner Scissor, Straight, 12.5cm Metzenbaum Sharp Scissor, Straight, 14.5cm Mayo Scissor, Curved, 14.5cm, TC Noyes Scissor, Curved, 15cm Metzenbaum Sharp Scissor, Curved, 14.5cm, TC Mayo Scissor, Straight, 14.5cm Metzenbaum Sahrp Scissor, Curved, 14.5cm Mayo Scissor, Straight, 18cm, TC Goldman Fox, Straight, 13cm Mayo Scissor, Curved, 14.5cm Barraquer/Gingiva Scissor, Straight, 15cm, TC Goldman Fox, Straight, 13 CM, Black, Super-cut, TC Goldman Fox, Curved, 13cm Metzenbaum Stump Scissor, Curved, 14.5cm, TC Kelly Scissor, Curved, 16cm Kelly Scissor, Straight, 16cm Metzenbaum Stump Scissor, Straight, 14.5cm Joseph Scissor, Curved, 14.5cm, TC Microsurgical Scissor, Straight, 14.5cm,TC Mayo Scissor, Straight, 18 cm Metzenbaum Stump Scissor, Curved, 14.5cm. Metzenbaum Fino Scissor, Straight, 14.5cm, TC Kelly Scissor, Straight, 16cm, TC Ligature 17C Band Pusher Bracket Positioning Tweezer, 14cm Ortho Arch Wire Tucker Measuring ruler, 0-60mm Ligature U15 Ortho Ligature Tucker Bracket Tweezer, 11cm Measuring ruler, 0-80mm Boons Gauge With Lid Band seater, Blue, 13cm Buccal Tube Holder Friedman, Fig. 1, 3mm, 14.5cm Friedman Mini, 2mm, 14.5cm Hemingway 2, 2.8mm Hemingway-3, 3.5mm Lucas 85, 2mm Soft Tissue Curette: Right Lucas 86, 3mm Lucas 85, 2.5mm Miller 8, 3.5mm Lucas 87, 3mm Soft Tissue Curette: Left Hemingway-1, 2. Lucas 84, 1.5mm Lucas 87, 3.5mm Hemingway-1, 2mm Lucas 84, 2mm Lucas 88, 4mm Lucas 86, 2.5mm Hemingway, 2.6mm Mathieu Needle Holder, Curved, 17cm, TC Mathieu Needle Holder, Straight, 14cm Mayo-Hegar Needle Holder, Curved, 16cm Mayo-Hegar Needle Holder, Straight, 16cm, TC Mathieu Needle Holder, Straight, 14cm, TC Castroviejo Micro Needle Holder, Barraquer, Curved, 16cm, TC Mayo-Hegar Needle Holder, Straight, 13cm, TC Fine Swedish Needle Holder, Straight, 15cm, TC Castervejio Micro Needle Holder, Straight, 18cm, TC Mathieu Needle Holder, Straight, 17cm Castroviejo Micro Needle Holder, Barraquer, Straight, 16cm, TC Crile-Wood Needle Holder, Straight, 18cm, TC Crile-Wood Needle Holder, Straight, 15cm Mathieu Needle Holder, Curved, 17cm Mathieu Needle Holder, Straight, 17cm, TC Lichtenberg Needle Holder, Straight, 17cm, TC Crile Ryde Needle Holder, Straight, 15cm, TC Crile-Wood Needle Holder, Straight, 15cm, TC Mathieu Needle Holder, Curved, 14cm Lichtenberg Needle Holder, Curved, 17cm, TC Castervejio Micro Needle Holder, Straight, 14cm, TC Mathieu Olsen Needle Holder, Straight, 17cm, TC Mathieu Needle Holder, Curved, 14cm, TC Explorer 23 + Probe CP 12 Explorer 6L + Probe CP 15 Endo Explorer Explorer 8 + Probe CP 2 Explorer 23 + Probe CP 2 Explorer 6 + Probe CP 2 Explorer 9 + Probe CP 18 Expros 23- WHO Probe CP, (ball-end) Expros 8- Probe CP 2 (ba Expros 23 - Probe CP 2 Explorer 8 + Probe CP 15 Explorer 8 + WHO Probe Explorer 23 + Probe CP 12B Expros 23- Probe CP 2 Expros 8- WHO Probe CP (ball-end) Explorer 8 + Probe CP 2B Explorer 23 + Probe CP 2B Explorer 23 + Probe CP 15 Exprlorer 23 + WHO Probe Root Canal Explorer Explorer Holst + Probe CP 18 Probe William + Explorer Holst Pen Model Intraligamental Syringe, Angled, 1.8 ml, 07 ml/ click, with Metric Thread Pistol Model Syringe, 1.8 ml, 0.2 ml/ click, with Metric Thread" Pen Model Intraligamental Syringe, 1.8 ml, 07 ml/ click, with Metric Thread" Cylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, without aspiration Cylinder Cartridge Syringe, 1.8 ml, Chrome-plated, with Metric Thread, without aspiration Self Aspirtning Syringe, Plastic and Metal, 2.2 ml, with Metric Thread Self Aspirating Syringe, Brass, 1.8 ml, with Metric Thread Self Aspirating Syringe, Plastic and Metal, 1.8 ml, with Metric Thread Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread Plastic Pipe for Pistol Syringe Cylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, with aspiration Kirkland

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-01-02
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2026-01-02
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2026-01-02
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2026-01-02
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2026-01-02
EIS	Remover, Crown	Dental	Class 1	872.4565	2026-01-02
EIG	Retractor, All Types	Dental	Class 1	872.4565	2026-01-02
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2026-01-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-01-02
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2026-01-02
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2026-01-02
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2026-01-02
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2026-01-02
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-01-02
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2026-01-02
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2026-01-02
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	2026-01-02
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2026-01-02
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2026-01-02
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2026-01-02
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2026-01-02
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2026-01-02
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2026-01-02
HTX	Rongeur	Orthopedic	Class 1	888.4540	2026-01-02
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2026-01-02
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2026-01-02
EKB	Explorer, Operative	Dental	Class 1	872.4565	2026-01-02
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2026-01-02
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2026-01-02

Official Correspondent

Qasim Raza

US Agent Details

.. .. Business: CMC Medical Devices LLC Email: fdaagent@cmcmedicaldevices.com Phone: (407) 2058993

Related Public Records

Same Entity

ErgoDenta ApS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
8040172	BURAQ SURGICAL CORP.	SIALKOT Punjab, PK
9681161	REBSTOCK INSTRUMENTS GMBH	DUERBHEIM Baden-Wurttemberg, DE
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043047788. Last updated year: 2026. Please use registration number 3043047788 when referencing this establishment in official correspondence.