Kerr Corporation

FDA Device Registration & Listing · ORANGE, CA, US · Registration 2024312

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2024312
FEI Number
2024312
Entity Name
Kerr Corporation
City/State/Country
ORANGE, CA, US
Establishment Address
1717 W Collins Ave, ORANGE, CA 92867, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
SYBRON DENTAL SPECIALTIES, INC. (Owner Number: 9029565)
Owner / Operator Contact Address
1889 W Mission Blvd, --, Pomona, CA 91766, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CoreRestore2 TF Adaptive Paper Points K3/K3XF Paper Points ZenFlex ONE Paper Points TF Paper Points Autofit Paper Points PAPER POINTS Water Cooled Impression Tray Originate Impression Trays Putty Spacer Three-In-One Impression Trays Clear Impression Trays Harmonize Composite SimpliShade Composite Kolor+ Plus Extrude Take 1 Hydro Bite Correct Plus Correct Quick Correct V.P.S. Optiguard Pre-contoured Metal Bands Cure-Thru Matrices Polishers Wedge Bags SuperCap Matrices, Steel, Cervical Locator Root Apex - Apex ID Bond 1 SF Bond-1 SF Solvent-Free SE Adhesive EndoTouch TC2 M4 TC2 Handpiece SimpliShade Self-Adhesive Flow Vertise Flow Alert Alert Condensable Composite OptiBond Universal 360 Embonte Temp-Bond Original Optibond XTR SmearClear K3XF Gutta Percha Elements Gutta Percha Cartridge TF Adaptive Gutta Percha SoftCore TF Adaptive Obturator TF Adaptive Verifiers Gutta Percha Cartridge Zenflex Pre-Tip Gutta Percha Gutta Percha ZenFlex ONE Gutta Percha Autofit Backfill Gutta Percha SimpliCore Obturator Universal SimpliFill Apical Plugs SimpliCore Obturator for Zenflex One Autofit Gutta Percha K3 Gutta Percha Tip Snip- GP Gauge Wheel with Stand TF Gutta Percha Vitality Scanner Apex Locator Vitality Scanner Tip SimpliShade BulkFill Flow SimpliShade BulkFill Self-Activating Capsules for Contour, Tytin, and Tytin FC GingiKNIT+ Nonimpregnated Retraction Cord GingiBRAID+ Nonimpregnated Retraction Cord GingiBRAID+ ShortCut Nonimpregnated Retraction Cord UniBRAID+ Nonimpregnated Retraction Cord Premise Indirect Facial Dentin Cervical High Spot Indicating Paste High Spot Indicating Spray Flex Tabs Silane Silane Primer NX3 Try-In Gels Revolution Formula 2 Dispensing Tips Bond-1 Primer & Adhesive 37% Phosphoric Acid Etching Gel OptiBond Gel Etchant Etching Gel KromaFaze Identic Integra Image Alignate Elements Diagnostic Unit Bond-1 Dual Cure Activator FibreKor Post FibreKleer 4x FibreKleer 4x Fiber Post FibreKleer Post FibreKor Fiber Post Impression Compound Take 1 Advanced Bite Correct VPS Putty Fusio SmearClear Mix Premise Flowable Herculite XRV Ultra Flow Pulp Canal Sealer Pulp Canal Sealer EWT Ruddle Post Removal System Permlastic Permlastic Adhesive Steri-Cassette Steri-Cage Take 1 Advanced elements e-motion VPS Adhesive Hawe Testset X-Ray Kwik-Bite Digital Imaging & Accessories Super-Bite Super-Bite Senso Endo-Bite Senso Hawe Imaging Plate Holder Test Modeling Resin TempSpan Dual-Cure Temporary Crown & Bridge Material TempSpan C&B Volume Machine OPTIMIX Premise OptiBond FL Elements Obturation Unit Elements Obturation Cartridge PeelVue+ Maxcem Elite Chroma SlickGel Temp-Bond NE OptiBond eXTRa Universal SimpliShade Bleach White Herculite Ultra Herculite XRV Ultra OptiShade Bleach White Perfect Pearl and Petite Pearl Prophy Contra Angles and Brushes PORCELAIN / CERAMICS NG Polishers & Prepolishers Pro-Brush GlossPlus Polisher Cup MINIDENTOFLEX Right Angle Mandrel COMPOSITE Glanzpolierer IDF Rec.Gloss Polishers Flame Pin Spannhalter Occlubrush Assorted Kit PINIDENTOFLEX GOLD/PRECIOUS ME PINIDENTOFLEX Pin-Holder MAXI SUPER ACRYLIC POLISHERs IDF Rec.Gloss Polishers Disc Occlubrush Cups & Points HiLuster Plus Polisher cup COMPOSITE Polishers & Prepolishers Opti1Step Polishers DIAMOND COMPOSITE Polishers COMPOSITE Vorpolierer IDF Rec.Gloss Polishers Mini HiLusterPlus Assortment OptiShine OptiClean IDF Rec.Gloss Polishers Cup MINIDENTOFLEX -COMPOSITE Polishers & Prepolishers Hawe Bristle Brushes IDF Rec.HiLuster Dia Polishers Hawe Polishing Assorted Kit GOLD/ AMALGAM / PRECIOUS METAL Polishers NTI Acrylic Polisher Ultimate FG IntraOral Logic Set CeraGlaze Porcelain Polishing Logic Set Prophy Brushes Zir-Cut Polisher Logic Set Cera-Glaze Ultimate Porcelain Logic Set NTI Green Abrasive Pro-Cup Latch Type Soft DiaGloss Polishing Logic Set Zir-Cut Zirconia Polisher Ortho Adhesive Removal Logic Set Acrylic Adjustment Logic Set NTI DiaGloss Polisher NTI PDQ Polisher AXIS Laminate Veneer Set NTI Brown Abrasive NTI Silicone Polisher CeraGlaze Intra-Oral Polishing Logic Set Valplast Logic Set UltraGloss Composite Polishing Logic Set Porcelain Adjusting & Polishing Logic Set Polisher Century Pack CeraGlaze Porcelain Lab Logic Set Personalized Logic Set Razor Sculpt and Polishing Logic Set Shammy Bright Discs NTI White Abrasive NTI Pink Abrasive PDQ Composite Polishing Brush Logic Set NTI Goldstar E4D Chairside Dental Designer Logic Set NTI CeraGlaze NTI PDQ2 Polisher ProGloss Ultimate Composite Polishing Logic Set Goldstar Gold Polishing Logic Set E4D Preparation Logic Set Pro-Cup Junior, Latch Type, Standard PDQ2 Composite Polishing Logic Set E4D Sdjust & Polish Logic Set Bite Adjustment Logic Set Interdental Wedges Clinical CAD/CAM Preparation Logic Set Pro-Cup Junior, Screw-Type, Standard Pro-Cup, Screw-Type, Soft EndoVac Apical Negative Pressure Irrigation System Construct Resin elements Connect Tytin FC Point 4 Transparent Construct System B Buchanan System B Plugger Harmonize Super clear GingiBRAID+ ShortCut Aluminum Potassium Sulfate Retraction Cord GingiBRAID+ Aluminum Potassium Sulfate Retraction Cord UniBRAID+ Aluminum Potassium Sulfate Retraction Cord GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord elements motor Flow-It ALC elements 8:1 Dental Handpiece Build-It Light Cure Material Cleanic Hawe Paste for Implants Luster Paste Prophy Paste Cleanpolish Superpolish Shammy Bright Polishing Paste Clinpro Premise Indirect Primary Dentin Take 1 Retraction Paste Ultrasonic Diamond Tip TF Adaptive Files Traverse Files TF (Twisted Files) ZenFlex Files Triple Flex Files K-Files LA Axxess Hedstrom Files Barbed Broach Pathfinder K-Flex Files Pathfinder CS K3XF Files Quantec Files ZenFlex One Sterile and Non-Sterile Files Traverse Orifice and Glide Path File Quantec Axxess Files Traverse Orifice Opener LightSpeed LSX K3 Files Root Canal Reamers LightSpeed CRX Traverse Glide Path File Tubli-Seal Xpress Tubli-Seal EWT Xpress Tubli-Seal EWT Tubli-Seal Temphase elements IC PacMac Heat Plugger Buchanan Hand Plugger Condensor ZenSeal Bioceramic Root Canal Sealer ZenSeal Disposable Tips OptiView OptiView Premier Demi Ultra TempBond Clear with Triclosan TempSpan Transparent Temporary Cement TempSpan Transparent NX3 Clear Light Guides for Curing Lights Premise Indirect Incisal OptiBond Solo Plus Biosplint Adhesive Zone ZoneFree FibreKor Fiber Post Drill FibreKleer 4X Fiber Post Drill Kerr Carbides Post Drills Bur Block Hawe Jet Carbides Jet Carbides LA Axxess BluWhite Carbides Axis Carbide Burs LVI Aesthetic Inlay/Onlay Logic Set GrayGates IPR Logic Set R.A.P.T.O.R. Resin Sculpting Logic Set MW Series Finishing Logic Set Crown Removal Logic Set Comprehensive Universal Cutter Logic Set Posterior Composite Logic Set TDF Carbide Logic Set Vylon Resources Logic Set Carbide Burs Melker Root Shaping Logic Set NTI Soft Tissue Trimmer Tri-fissure All Ceramic Logic Set E$D Sample Logic Set All-Purpose Esthetic Logic Set TDF Series Personalized Logic Set Endodontic Access Logic Set Lowe Crown & Bridge Logic Set TDF Series Composite Logic Set Razor T&F Carbides Barbed Broaches Reamers Pulp Canal Composite Surface Treatment OptiDisc SonicFill Handpiece, MULTIFlex Coupling, Lubrication Spray OptiBond Universal OptiBond All-In-One EndoRing SimpliCore Universal Verifier SimpliCore Verifier for Zenflex One PeelVue Pro Demi Plus Replacement Battery Pack Softline Mixing Tips Automix Tips Bayonet Rings Intra-oral Tips Free-Flo Syringe, Tips Root Canal Tips Dynamic Mixing Tips Wastesaver Tips Static Mix Tips Dispensing Tips Nexus Universal Nexus Universal Chroma Touch N Heat Spoon Tip Touch N Heat Carrier Hot Pulp Test Tip Touch N Heat Plugger Steri-Mat Size B Tray - Divided Point 4 Life Opaque Dual Cure Resin Carr Explorer Mojo Try-In Gels Mojo Comporoller Gates Glidden Drills Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips Chamfer Preparation Logic Set Veneer Preparation Logic Set Axial Reduction - MADC Raintree Essix Logic Set Zir-CUT Substructure Logic Set CEREC Starter Logic Set Belvedere C.C.V. Logic Set CEREC Prep N' Glaze Logic Set TDF Diamond Logic Set All Ceramic Logic Set LVI Anterior Direct Ressin Preparation Logic Set Hornbrool Prep Logic Set Anterior Composite Logic Set Laminate Veneer Logic Set Axial Reduction Logic Set TDF Series Composite Logic Set LA Axxess Nano Diamonds CEREC Prep & Finish Logic Set ZIR-CUT Diamond Bambino Diamonds KS Series Guide Pin Diamond Intensiv ProxoShape Diamond File Zir-Cut DDS Adjusting Logic Set Nano Prep Diamond Logic Set Personalized Logic Set Turbo Chamfer Preparation Logic Set BruxZir Logic Set Reverse Preparation Logic Set TDF Series Hornbrook Finish Logic Set Logic Set Axis Diamond Burs CEREC Intra-Oral Art & Passion Logic Set R.A.P.T.O.R. Diamond Modified Shoulder Logic Set Turbo Diamonds LAVA Preparation Logic Set Composite Logic Set LVI Esthetic Preparation Logic Set cerecdoctors.com Logic Set Radz & Soileau RSVP Logic Set BluWhite SimpliCut Pre-Sterile Diamond Burs Discovery Trays Apex Connect SoftClamp Nexus RMGI Breeze RMGI Bond-It Enamel/Dentin Bonding System Bond-It Primer Bite Wafer Disclosing Wax Occlusal Indicator Wax

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2005-11-14
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1977-12-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2017-01-05
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EAX Mirror, Mouth Dental Class 1 872.4565 1996-10-02
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2010-01-04
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
JEP Retainer, Matrix Dental Class 1 872.4565 1995-09-13
LQY Locator, Root Apex Unknown Class U N/A 2021-04-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-04-27
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-05
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2019-07-01
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-03-17
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2023-01-14
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 2006-08-07
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2010-11-10
KJJ Cleanser, Root Canal Unknown Class U N/A 2007-11-05
EKM Gutta-Percha Dental Class 1 872.3850 2001-01-09
EAT Tester, Pulp Dental Class 2 872.1720 2011-09-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2022-11-08
DZS Capsule, Dental, Amalgam Dental Class 1 872.3110 1997-08-05
MVL Cord, Retraction Unknown Class U N/A 2018-01-09
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EFH Paper, Articulation Dental Class 1 872.6140 2007-01-26
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-11-01
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
ELW Material, Impression Dental Class 2 872.3660 2016-07-06
EAT Tester, Pulp Dental Class 2 872.1720 2007-11-05
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-11-01
ELR Post, Root Canal Dental Class 1 872.3810 2008-12-01
ELW Material, Impression Dental Class 2 872.3660 2011-12-06
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
ELW Material, Impression Dental Class 2 872.3660 2011-11-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EKQ Preparer, Root Canal Endodontic Dental Class 1 872.4565 2019-01-03
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-05
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-05-16
EJY Pliers, Operative Dental Class 1 872.4565 2012-11-26
ELW Material, Impression Dental Class 2 872.3660 2011-11-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2017-05-04
ELW Material, Impression Dental Class 2 872.3660 2013-06-10
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2019-04-18
ELW Material, Impression Dental Class 2 872.3660 2019-11-25
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 1996-03-19
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2011-10-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2011-11-01
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2005-09-01
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2007-06-27
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2014-12-29
EMA Cement, Dental Dental Class 2 872.3275 2015-08-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2007-11-05
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
KJJ Cleanser, Root Canal Unknown Class U N/A 2021-04-23
EMA Cement, Dental Dental Class 2 872.3275 2006-08-07
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2011-09-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2018-11-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EHL Point, Abrasive Dental Class 1 872.6010 1996-07-16
NYL Handpiece, Air-Powered, Root Canal Irrigation Dental Class 1 872.4200 2014-07-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2022-09-23
LQY Locator, Root Apex Unknown Class U N/A 2022-09-23
EJJ Alloy, Amalgam Dental Class 2 872.3070 2011-11-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2011-10-31
EAT Tester, Pulp Dental Class 2 872.1720 2007-06-27
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-08-01
ELW Material, Impression Dental Class 2 872.3660 2018-01-09
MVL Cord, Retraction Unknown Class U N/A 2018-01-09
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2017-07-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2017-07-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-11-01
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2000-01-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
MVL Cord, Retraction Unknown Class U N/A 2020-12-28
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-11-05
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1996-10-02
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2016-08-15
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2007-11-05
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1996-10-02
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2023-08-09
EIG Retractor, All Types Dental Class 1 872.4565 2005-04-29
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2019-11-25
EMA Cement, Dental Dental Class 2 872.3275 2011-10-31
EMA Cement, Dental Dental Class 2 872.3275 2011-10-31
EAY Light, Fiber Optic, Dental Dental Class 1 872.4620 1992-08-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EMA Cement, Dental Dental Class 2 872.3275 2015-09-10
EJL Bur, Dental Dental Class 1 872.3240 1993-11-12
EKP Reamer, Pulp Canal, Endodontic Dental Class 1 872.4565 2003-08-05
EHJ Disk, Abrasive Dental Class 1 872.6010 1996-03-20
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-07-24
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-10-31
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2003-08-05
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2019-03-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2019-03-14
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2021-04-12
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-12-01
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 1977-12-15
EMA Cement, Dental Dental Class 2 872.3275 2019-11-21
EAT Tester, Pulp Dental Class 2 872.1720 2011-09-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-06-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 1984-07-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-10-31
EKB Explorer, Operative Dental Class 1 872.4565 1989-05-22
EMA Cement, Dental Dental Class 2 872.3275 2011-11-01
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 1985-05-28
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 1999-03-30
DZN Instruments, Dental Hand Dental Class 1 872.4565 2005-08-10
DZP Instrument, Diamond, Dental Dental Class 1 872.4535 2014-02-13
KMT Tray, Fluoride, Disposable Dental Class 1 872.6870 1977-12-15
LQY Locator, Root Apex Unknown Class U N/A 2022-09-16
EEF Clamp, Rubber Dam Dental Class 1 872.6300 2006-03-10
EMA Cement, Dental Dental Class 2 872.3275 2013-02-21
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-11-01
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 1977-12-15

Official Correspondent

Jennifer Evans

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SYBRON DENTAL SPECIALTIES, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027500898 EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada Escazu, San Rafael San Jose, CR
3003848022 Metrex Research LLC Madison, WI, US
1722021 METREX RESEARCH Romulus, MI, US
3031606517 Envista (Sichuan) Medical Device Co., Ltd. Ziyang Sichuan, CN
3028340833 EH Labs CZ s.r.o. Dvur Kralove nad Labem Hradec Kralove, CZ

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0011-2020 Inter-Med Llc U
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024312. Last updated year: 2026. Please use registration number 2024312 when referencing this establishment in official correspondence.
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