meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
54
Latest Decision
1987-01-07

Clearances · page 111 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862286 ARTHROPHONOMETER Arthrotek, Inc. NFQ Class I 1987-01-07
K864321 MICRO-VENT Core-Vent Corp. DZE Class II 1987-01-07
K864346 REMBRANDT PORCELAIN TINTING KIT Den-Mat Corp. EBF Class II 1987-01-07
K863237 HYDROXYLAPATITE BONE GRAFT MATERIAL Richards Medical Co., Inc. LYC Class II 1986-12-29
K864270 3M GLASS IONOMER LINER 3M Company EMA Class II 1986-12-16
K864051 TUBULICID RED LABEL Dental Dimensions Supply Co. LBH Class II 1986-12-10
K864053 TUBULITEC LINER Dental Dimensions Supply Co. EJK Class II 1986-12-05
K864050 TUBULICID BLUE LABEL Dental Dimensions Supply Co. LBH Class II 1986-12-05
K864052 TUBULITEC PRIMER Dental Dimensions Supply Co. LBH Class II 1986-12-05
K862177 IDEX DENTAL IMPLANT R. J. Chapman, D.M.D. DZE Class II 1986-12-02
K863288 HYDROPHILIC REPROSIL Dentsply Intl. ELW Class II 1986-12-01
K863176 ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ Coors Biomedical Co. LYC Class II 1986-11-26
K863876 OMNI-FIL Inpromas EBF Class II 1986-11-26
K864306 VERINOR ALLOY Degussa Dental, Inc. EJT Class II 1986-11-26
K864474 DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC Planmeca USA, Inc. EHD Class II 1986-11-26
K864404 PENTRON HIGH STRENGTH PORCELAIN Pentron Corp. EIH Class II 1986-11-24
K864300 SILIVA EJECTOR/ORAL CAVITY EVACUATOR Ardent Intl., Inc. DYN Class I 1986-11-24
K863742 FLEXMEDICS NITINOL ARCH WIRE Flexmedics DZC Class I 1986-11-24
K864059 DENTAL PROPHY CUPS (VARIOUS TYPES) Mission White Dental, Inc. EHK Class I 1986-11-19
K864307 MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) Smith & Nephew, Inc. EIC Class I 1986-11-18
K864096 DREAM DAM Dental Dam, Inc. EIE Class I 1986-11-18
K864215 PROPHY CARE SOLUTION Imd, Inc. EJR Class I 1986-11-18
K863882 OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE Coe Laboratories, Inc. EBF Class II 1986-11-18
K863401 RECOVER Scientific Pharmaceuticals, Inc. EBF Class II 1986-11-13
K863782 NPG NONPRECIOUS CROWN AND BRIDGE ALLOY Aalba Dent, Inc. EJH Class II 1986-11-07
K862384 SCHEIN AP-1 AIR POLISHING UNIT Henry Schein, Inc. KOJ Class II 1986-11-07
K863755 VENT-PLANT DENTAL IMPLANT, OSSEOLOCK AND ROBUTMENT Vent-Plant Corporation, Inc. DZE Class II 1986-11-07
K861425 SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT Core-Vent Corp. DZE Class II 1986-11-05
K863421 SR-IVOLEN TRAY MATERIAL Ivoclar USA, Inc. EBH Class I 1986-11-03
K864162 DEGUPAL Degussa Dental, Inc. EJS Class II 1986-11-03
K863638 GUTTA PERCHA POINTS Endodent, Inc. EKM Class I 1986-10-30
K863769 EVACUATOR TIPS The Medical Group, Inc. EHZ Class I 1986-10-30
K863998 COLTENE JET-MIXER Coltene, Inc. EID Class I 1986-10-30
K863411 GUTTA PERCHA Endodent, Inc. EKM Class I 1986-10-30
K863766 DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY The Medical Group, Inc. EAX Class I 1986-10-30
K862385 SCHEIN BLEACHING UNIT Henry Schein, Inc. EEG Class I 1986-10-30
K863767 GLASS MOUTH MIRRORS, REUSABLE The Medical Group, Inc. EAX Class I 1986-10-30
K863243 SHINER STRESS DIRECTING ATTACHMENT Js & R - R & D Co. EGG Class I 1986-10-30
K863768 SALIVA EJECTORS The Medical Group, Inc. DYN Class I 1986-10-27
K863816 IVORY PREMIUM RUBBER DAM Columbus Dental Mfg. Co. EIE Class I 1986-10-27
K863764 COTTON ROLLS, NON-STERILE The Medical Group, Inc. EFN Class I 1986-10-27
K864008 ACCLAIM* BRACKET ADHESIVE Johnson & Johnson Professionals, Inc. DYH Class II 1986-10-24
K862930 PERFECT ONE North American Alloys, Inc. EJH Class II 1986-10-24
K863680 IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS Interpore Intl. DZE Class II 1986-10-24
K861601 DP32 HAND HELD DENTAL PROPHYLAXIS UNIT Stewart J. Lustgarten EIA Class I 1986-10-17
K863552 IMPROVED COMSPAN Dentsply Intl. EBF Class II 1986-10-17
K863831 VIVADENT FILPIN Vivadent (Usa), Inc. EBL Class I 1986-10-14
K863836 POST TRAY Market Masters, Inc. EHY Class I 1986-10-14
K862546 MICROFILL PONTIC Kulzer, Inc. EBF Class II 1986-10-14
K863799 JAW FIXATION ASSEMBLY Medical Products & Research, Inc. DYX Class II 1986-10-14
K863174 CAULK'S POLISHING PASTE Dentsply Intl. EBF Class II 1986-10-07
K861426 SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT Core-Vent Corp. DZE Class II 1986-10-07
K863758 ORTHO-BITE WAX WAFER Columbus Dental Mfg. Co. EGD Class I 1986-10-07
K863677 TRADITION HIGH SPEED HANDPIECE Midwest EFB Class I 1986-10-06
K863028 ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY Ross Implant Technologies Corp., Inc. DZE Class II 1986-10-06
K863676 GENTEEL Luben Dental Co., Inc. ELC Class II 1986-10-02
K863016 DENTATUS L SET Sds Dental, Inc. KLC Class I 1986-10-01
K863021 CM-II, CM-I WATER UNIT Sds Dental, Inc. EIA Class I 1986-10-01
K863019 F-11 REFLECTOR / F-II STANDARD REFLECTOR Sds Dental, Inc. EAZ Class I 1986-09-29
K863010 EUROCART SR-4, EUROCART M-IV, ISOCART III Sds Dental, Inc. EIA Class I 1986-09-26
K862224 THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES Xouth, Inc. JEQ Class I 1986-09-26
K862879 NEW LIGHT-CURING IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1986-09-25
K863157 RESTODENT POSTERIOR Lee Pharmaceuticals EBF Class II 1986-09-25
K863024 SERINGA TRIPLICE S.L. Sds Dental, Inc. ECB Class I 1986-09-25
K863023 CABINET II AUXILIARY UNIT Sds Dental, Inc. EIA Class I 1986-09-25
K862635 RABINOWITZ GUM MASSAGER Arnell, Inc. JEW Class I 1986-09-25
K863009 GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX Sds Dental, Inc. EJP Class I 1986-09-25
K863133 PROPHY CARE PASTE Imd, Inc. EJR Class I 1986-09-25
K861681 DENTIMEDIC DENTAL EMERGENCY KIT Dentimedic EMB Class I 1986-09-23
K863315 MULTIFIL(R) VS Kulzer, Inc. EBF Class II 1986-09-22
K863314 ESTILUX(R) POSTERIOR C Kulzer, Inc. EBF Class II 1986-09-22
K863500 STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR Pacific Union Dental, Inc. EIS Class I 1986-09-22
K863163 ULS 8-86 American Instrument Manufacturer'S, Inc. DYN Class I 1986-09-22
K863031 TWIN-CORE Scientific Pharmaceuticals, Inc. EBF Class II 1986-09-22
K863092 DENTAL COMPOSITE RESTORATIVE Dentsply Intl. EBF Class II 1986-09-19
K862829 PANAGRAF Panadent International, Inc. KLE Class II 1986-09-19
K863484 SIEMENS SIRONA(R) DENTAL CHAIR Pelton & Crane Co. KLC Class I 1986-09-19
K863375 SEA-BOND Combe, Inc. KXX Class I 1986-09-19
K863522 MODIFIED SELF-CURE BONDING AGENT Dentsply Intl. KLE Class II 1986-09-19
K862942 PHOTO CLEARFIL BRIGHT Kuraray Co. EBF Class II 1986-09-05
K862532 DUMBACH TITANIUM MESH IMPLANT SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 1986-09-05
K863324 TRIAD IMPACT Dentsply Intl. EBI Class II 1986-09-05
K862822 REXILLIUM N. B. F. Jeneric Ind. EJH Class II 1986-09-02
K862926 SURGICAL VITEX Jeneric Ind. ELE Class II 1986-08-29
K862876 NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM Block Drug Company, Inc. KOO Class I 1986-08-29
K863141 KULZER GLASS IONOMER LINER Shofu Dental Corp. EMA Class II 1986-08-26
K863131 PIK POCKET (IRRIGATING TIP) Teledyne, Inc. EFS Class I 1986-08-26
K863097 CB BUR Beavers Dental, Div. Sybron Canada, Ltd. EJL Class I 1986-08-26
K862856 PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR Austenal Dental, Inc. EJS Class II 1986-08-26
K862292 ESPE VISIO-MOLAR Espe GmbH (Us) EBF Class II 1986-08-18
K862499 ULTRACAST Ultratek EJH Class II 1986-08-18
K862324 OSTEOGRAF/AR AND OSTEOGRAF/AR+ Coors Biomedical Co. LYC Class II 1986-08-15
K862870 RESISTAL P Degussa Dental, Inc. EJH Class II 1986-08-15
K862912 RENAMELIZE POLISHING PASTE Cosmedent, Inc. EJR Class I 1986-08-12
K862534 PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS Walter Lorenz Surgical, Inc. JEY Class II 1986-08-07
K862110 OSSEODENT DRILLING SYSTEM Otc/America KMW Class II 1986-08-07
K862505 MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 1986-08-07
K862694 FLOSS CARD Floss Card Co. JES Class I 1986-08-06
K861338 DENTAL COTTON ROLLS, STERILE AND NON-STERILE Intl. Verbandstoff-Fabrik Schaffhau EFN Class I 1986-08-06
K862533 MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE Walter Lorenz Surgical, Inc. JEY Class II 1986-08-01

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