FDA Device Registration & Listing · Dallas, TX, US · Registration 3012101664
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2019-07-10 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2016-09-28 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2025-06-16 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2019-07-10 |
| ELA | Instrument, Hand, Calculus Removal | Dental | Class 1 | 872.4565 | 2016-09-28 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-10 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2019-07-10 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2016-09-28 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2019-07-10 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-06-16 |
| EJP | Articulators | Dental | Class 1 | 872.3150 | 2016-09-28 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-06-16 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2021-08-27 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2016-09-28 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-07-10 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-09-28 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-06-08 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2016-09-28 |
| NPK | Barrier, Synthetic, Intraoral | Dental | Class 2 | 872.3930 | 2025-03-12 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2016-09-28 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-10 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2016-09-28 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-06-16 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2026-06-20 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2016-05-29 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2016-09-28 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-10 |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits | Dental | Class 1 | 872.3980 | 2022-04-11 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2016-05-29 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2016-05-29 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2016-09-28 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2016-02-08 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2016-09-28 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-07-10 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2016-02-08 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2016-09-28 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2016-05-30 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2016-09-28 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K241486 | Covidien | Sofsilk Coated Braided Silk Suture | 2024-12-03 |
| K123940 | Demetech Corp. | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | 2014-05-30 |
| K050845 | ETHICON, Inc. | MONOCRYL PLUS ANTIBACTERIAL SUTURE | 2005-06-29 |
| 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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0010-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0011-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0012-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0013-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1836161 | ASPEN SURGICAL PRODUCTS, INC. | Caledonia, MI, US |
| 3003956316 | COMMIC SURGICO | SIALKOT Punjab, PK |
| 3003877407 | ZAIN'S MEDICAL IMAGE | SIALKOT Punjab, PK |
| 3042244574 | LLD CARE D.O.O. | Zagreb Zagreb, Grad, HR |
| 3014937043 | CONFIDENT INSTRUMENTS | Sialkot Punjab, PK |
3012101664 when referencing this establishment in official correspondence.