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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
41
Latest Decision
1992-03-02

Clearances · page 96 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K914035 MINI-MILL Biomedical Composites, Ltd. EMI Class I 1992-03-02
K915249 VERA PDS & VERA PDI Aalba Dent, Inc. EJH Class II 1992-03-02
K915847 AUTOMIX DENTAL AMALGAMATOR Kerr Corporation (Danbury) EFD Class I 1992-03-02
K915830 PRISMA UNIVERSAL BOND(R) 3 Dentsply Intl. KLE Class II 1992-03-02
K920561 DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. Ivoclar North America, Inc. EJH Class II 1992-03-02
K915654 KERALLOY-D CAPS Wilde-USA, Inc. EJJ Class II 1992-03-02
K910069 SR-ISOSIT SPECTRA LINK SYSTEM Ivoclar North America, Inc. KLE Class II 1992-03-02
K920016 IMPROVED DENTAL CHAIR Den-Tal-Ez Mfg Co., Inc. KLC Class I 1992-03-02
K915618 PROVICOL Voco GmbH EMA Class II 1992-02-25
K913974 ACCESS IMPRESSION BARREL Centrix, Inc. EID Class I 1992-02-25
K915626 EZ GOLD Ivoclar North America, Inc. EJT Class II 1992-02-25
K915619 IONOFIL/LONOFIL MOLAR Voco GmbH EMA Class II 1992-02-25
K913417 ETEX DENTAL IMPLANT SYSTEM Etex Co. DZE Class II 1992-02-19
K915207 DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP Bay Technical Products, Inc. EEF Class I 1992-02-14
K912059 PRE-ANGLED ABUTMENTS Core-Vent Corp. DZE Class II 1992-02-11
K903999 OBUTMENT HB O Co., Inc. DZE Class II 1992-02-11
K915597 BUR,DENTAL (76EJL) Calcitek, Inc. DZE Class II 1992-02-05
K912993 WILDE DENTURE RESINS Wilde-USA, Inc. EBI Class II 1992-02-03
K915336 TWINLOOK Heraeus Kulzer, Inc. EBF Class II 1992-02-03
K913200 GTI CLASP COVER Gti, Inc. EBF Class II 1992-02-03
K915466 SEPTOPACK TEMPORARY FILLING Specialites Septodont EBG Class II 1992-02-03
K915467 CIMPAT S DENTAL CEMENT Specialites Septodont EMA Class II 1992-02-03
K914612 MERON DENTAL CEMENT Voco GmbH EMA Class II 1992-02-03
K915276 DENTURE PLASTIC TEETH,76 ELM Nobelpharma USA, Inc. ELM Class II 1992-02-03
K915299 COGAN CORP KITS OF DENTAL HAND INSTRUMENTS Cogan Corp. EGG Class I 1992-01-31
K915111 PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD Metalor Dental USA Corp. EJT Class II 1992-01-31
K915377 SR-IVOCAP PLUS Ivoclar North America, Inc. EBI Class II 1992-01-31
K915355 ADS-GEL AND INSULATING-GEL Heraeus Kulzer, Inc. EBF Class II 1992-01-31
K913348 THE STERN ERA SYSTEM Sterngold/Implamed DZE Class II 1992-01-30
K913769 SYREX SYRINGE Special Machinery Co. EJI Class II 1992-01-23
K915243 TOUCH 'N HEAT MODEL 5002, MODIFICATION Analytic Technology EKM Class I 1992-01-21
K915335 SILICOATER SYSTEM Heraeus Kulzer, Inc. EBF Class II 1992-01-21
K914437 CORRECT-S.I.M. Jeneric/Pentron, Inc. ELW Class II 1992-01-17
K902433 DIA ANATOMIC ABUTMENT Dental Imaging Assoc., Inc. DZE Class II 1992-01-17
K912632 OCCLUDE Pascal Co., Inc. EFH Class I 1992-01-17
K914764 STERN ERA IMPLANT ABUTMENT Sterngold/Implamed DZE Class II 1992-01-17
K915095 ESTISEAL LC Heraeus Kulzer, Inc. EBC Class II 1992-01-17
K895901 VITA CEREC SET AND VITA CEREC BLOCS Vident ELW Class II 1992-01-17
K914727 SEQUENCE LIGHT CURE ADHESIVE Ormco Corp. DYH Class II 1992-01-17
K913814 MODEL #05 ANEROID SPHYGMOMANOMETER KIT National Health-Care Equipment, Inc. ELY Class II 1992-01-16
K911776 DPI-1106 IMPLANT, MODIFICATION Minimatic Implant Technology DZE Class II 1992-01-15
K913651 MANI DIA-BURS The Lahr Consulting Group, Inc. DZP Class I 1992-01-14
K913854 ORTHO LIGHT CURE Ortho Source DYH Class II 1992-01-14
K913966 SONO(R) -CEM Espe GmbH (Us) EBF Class II 1992-01-14
K915005 PHOTAC-BOND APLICAP, MODIFICATION Espe GmbH (Us) EMA Class II 1992-01-14
K912001 CONVERTRAY, MODIFICATION Wilde Dental (Usa) ELW Class II 1992-01-09
K912734 INTERPORE HEX HEAD IMPLANT RESTORATIVE COMPONENTS Interpore Intl. DZE Class II 1992-01-08
K911061 ESPE KETAC-ENDO APLICAP H.A. Opotow Consulting EMA Class II 1992-01-03
K915247 NPG III CASTING ALLOY Aalba Dent, Inc. EJH Class II 1991-12-30
K915248 LPG CASTING ALLOY Aalba Dent, Inc. EJH Class II 1991-12-30
K914962 FUN FLOSS Fun Floss Co. JES Class I 1991-12-30
K913175 MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES G-C Intl. Corp. EJJ Class II 1991-12-27
K915353 MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP Matrix Medica, Inc. EIA Class I 1991-12-27
K914324 CAVITY VARNISH PRODUCT Confi-Dental Products Co. EMA Class II 1991-12-27
K912994 COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE Wilde-USA, Inc. EBZ Class II 1991-12-23
K912417 MOLAR DISTALIZING ASSEMBLY American Orthodontics DYJ Class I 1991-12-20
K911960 BRANEMARK SYSTEM-3.0MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1991-12-19
K912991 WILDE AUXILIARIES Wilde-USA, Inc. EBI Class II 1991-12-19
K914198 POWER FLOSS AND BRUSH EW 129 & EW 120 Matsushita Electric Co. JEQ Class I 1991-12-18
K913980 HELIOLUX Ivoclar North America, Inc. EBZ Class II 1991-12-16
K914003 MIDAS BRACKET Gold'N Braces, Inc. EJF Class I 1991-12-16
K913857 ROCATEC(R) -PLUS Espe GmbH (Us) EJH Class II 1991-12-16
K912262 HEXLOCK Imtec Corp. DZE Class II 1991-12-10
K914186 ULTRACROWN(TM) PRE-SOLDER Dentsply Intl. EJT Class II 1991-12-09
K914041 MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT Midwest Implant Sales, Inc. DZE Class II 1991-12-09
K914042 MIDWEST IMPLANT HEXED 3.75MM SELF TAPPING IMPLANT Midwest Implant Sales, Inc. DZE Class II 1991-12-09
K912682 ORTHODONTIC HEADGEAR K-Tek Orthodontic Products DZB Class II 1991-12-09
K914043 MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA Midwest Implant Sales, Inc. DZE Class II 1991-12-09
K904391 VIDENT IMPAC IMPLANT ACCESSORIES Vident DZE Class II 1991-12-09
K913965 ESPE(R) -SIL Espe GmbH (Us) KLE Class II 1991-12-04
K913946 IMPERVA DUAL Shofu Dental Corp. KLE Class II 1991-12-03
K904236 ENDOSSEOUS IMPLANTS Attachments Intl., Inc. DZE Class II 1991-11-27
K913913 REFURBISHED ORTHODONTIC APPLIANCES Ortho-Cycle Co. EJF Class I 1991-11-27
K914616 KLEER(TM) ORTHODONTIC BRACKET Ormco Corp. EJF Class I 1991-11-20
K911118 DTF-1000LL,DTF-1000 Cp Medical EIB Class I 1991-11-20
K913519 SUMO GLASS IONOMER CEMENT Ortho Source EMA Class II 1991-11-19
K911111 MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS Vermont Diamond Instruments EHJ Class I 1991-11-19
K914627 PLATINUM FOIL PLATINUM MILING WAFER Metalor Dental USA Corp. EJS Class II 1991-11-13
K913704 ARGEBOND 80 Argen Precious Metals, Inc. EJS Class II 1991-11-13
K914340 DUOMAT 3 AMALGAMATOR Degussa AG EFD Class I 1991-11-13
K913860 ULTRACROWN(TM) PD ALLOY POST-SOLDER Dentsply Intl. EJS Class II 1991-11-13
K913464 STOMAVISION (STV) Trophy Radiologie EIA Class I 1991-11-13
K914341 MIXOMAT AMALGAMATOR Degussa AG EFD Class I 1991-11-13
K913583 CONVERSIL FL AND CONVERSIL P Wilde-USA, Inc. ELW Class II 1991-11-13
K914368 PART 872 DEGUFILL H & DEGUFILL M DA Degussa AG EKJ Class I 1991-11-13
K912992 KERALLOY NON-GAMMA 2 AMALGAM Wilde-USA, Inc. EJJ Class II 1991-11-13
K914697 MDT/CASTLE PURUS DENTAL UNIT Mdt Corp., Inc. EIA Class I 1991-11-13
K914339 DENTOMAT 3 AMALGAMATORS Degussa AG EFD Class I 1991-11-07
K913573 SAFETY PLUS DENTAL INJECTION NEEDLE Specialites Septodont DZM Class I 1991-11-07
K912893 ORTHOPANTOMOGRAPH 100 Instrumentarium Corp. EHD Class II 1991-11-05
K913652 COFFMAN TOMOGRAPH Coffman Dental EHD Class II 1991-10-30
K912142 MICRONAIRE ISO-HOOD MAX 5UV Micronaire Corp. EAZ Class I 1991-10-30
K912997 MINIFLEX AND PERSONAL UNIT Dabi-Atlante America Corp. EAZ Class I 1991-10-30
K913782 TCAL ABUTMENT Core-Vent Corp. DZE Class II 1991-10-30
K913884 FUJI II LC G-C Intl. Corp. EMA Class II 1991-10-30
K913405 KAR-D-TEK Gresco Products, Inc. LFC Class II 1991-10-28
K913372 IPS EMPRESS Ivoclar North America, Inc. EIH Class II 1991-10-25
K911756 POSTERIOR NASAL EPISTAXIS INSTRUMENTS Richard Wolf Medical Instruments Corp. ECB Class I 1991-10-24
K914322 BARITONE C2 & BARITONE L3 Confi-Dental Products Co. EBC Class II 1991-10-23
K914319 PIT AND FISSURE SEALANT PRODUCTS Confi-Dental Products Co. EBC Class II 1991-10-23

12,679 clearances in the Dental panel. Data: openFDA.