meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2000-03-14

Clearances · page 68 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K994285 ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH Dentsply Intl. EHD Class II 2000-03-14
K000311 PARAPOST FIBER WHITE Coltene/Whaledent, Inc. ELR Class I 2000-03-14
K994357 BITEM LOCK, MODELS SW006, SW012 Thermoelastic Technologies, Inc. EJF Class I 2000-03-14
K993894 LIFECORE SINGLE TOOTH ABUTMENT SYSTEM Lifecore Biomedical, Inc. DZE Class II 2000-03-08
K994299 ART-P3, MODEL P3-1-ART-A1 Bonart Co., Ltd. ELC Class II 2000-03-06
K994203 ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 Bonart Co., Ltd. ELC Class II 2000-03-06
K994144 TOOTHBRUSH WASH Cal Huech, Inc. EFW Class I 2000-03-02
K994180 PULPDENT CAVITY PREPARATION III Pulpdent Corp. LBH Class II 2000-03-02
K993610 CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 Osteogenics Biomedical, Inc. LYC Class II 2000-03-02
K994205 MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 2000-02-29
K000173 CEMENT IT! UNIVERSAL C&B Jeneric/Pentron, Inc. EMA Class II 2000-02-29
K992937 DENTAL IMPLANT Nobel Biocare Uas, Inc. DZE Class II 2000-02-29
K994181 PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE Pulpdent Corp. LBH Class II 2000-02-29
K993514 DEFINITE Degussa - Ney Dental, Inc. EBF Class II 2000-02-24
K994182 PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE Pulpdent Corp. LBH Class II 2000-02-23
DEN990002 KAVO DIAGNODENT Kavo America NBL Class II 2000-02-22
K000360 RX G-UNIVERSAL Jeneric/Pentron, Inc. EJT Class II 2000-02-18
K994298 FRIOS MICROSAW Friadent GmbH KMW Class II 2000-02-18
K994012 TEMPOFIT, MODEL 02693 Detax GmbH & Co. KG EBG Class II 2000-02-16
K993846 ULTRASEAL XT PLUS Ultradent Products, Inc. EBC Class II 2000-02-16
K994154 MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES KLS-Martin L.P. JEY Class II 2000-02-15
K993958 IDX-60 INTRAORAL X-RAY X-Cel X-Ray Corp. MUH Class II 2000-02-14
K993224 T-GEAR, MODEL TG/400-700 Dontech Products B.V. DZB Class II 2000-02-11
K992176 EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL St. George Technology, Inc. EBI Class II 2000-02-10
K994435 OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS Jeneric/Pentron, Inc. EIH Class II 2000-02-10
K994172 CEREC 3 Sirona Dental Systems GmbH ELW Class II 2000-02-08
K992854 ARTIFICIAL TEETH (ACRYLIC TEETH) Masterdent Ltda. ELM Class II 2000-02-07
K994304 ARABESK FLOW Voco GmbH EBF Class II 2000-02-07
K994302 RESIN TOOTH BONDING AGENT Parkell, Inc. KLE Class II 2000-02-07
K000149 NOVABONE-BIOGLASS BONE GRAFT PARTICULATE Usbiomaterials Corp. LYC Class II 2000-02-07
K994268 ARABESK TOP Voco GmbH EBF Class II 2000-02-03
K994024 EXTENDED STRAIGHT ATTACHMENT Team Technologies, Inc. EGS Class I 2000-02-03
K000120 PRO-TORQ Micro Motors, Inc. EBW Class I 2000-02-03
K993917 TOKUYAMA ONE-UP-BOND F Tokuyama America, Inc. KLE Class II 2000-02-02
K994261 ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT Ultradent Products, Inc. EMA Class II 2000-02-02
K992648 ROTARY MASTER J. Morita USA, Inc. EBW Class I 2000-01-31
K994224 PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL Prime Dental Manufacturing, Inc. EBF Class II 2000-01-31
K000065 CAMLOG CYLINDER IMPLANT SYSTEM Altatec Biotechnologies DZE Class II 2000-01-28
K993595 NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) Nobel Biocare Uas, Inc. DZE Class II 2000-01-28
K984297 MAGNA ABUTMENT Factor, Ii, Inc. DZE Class II 2000-01-28
K994192 IMPREGUM PENTA M MONOSOFT Espe Dental AG ELW Class II 2000-01-28
K000099 CAMLOG SCREW IMPLANT SYSTEM Altatec Biotechnologies DZE Class II 2000-01-28
K000100 CAMLOG ROOTFORM IMPLANT SYSTEM Altatec Biotechnologies DZE Class II 2000-01-28
K994193 IMPREGUM PENTA DUOSOFT Espe Dental AG ELW Class II 2000-01-28
K994077 AROMA FINE (NORMAL AND FAST SET) GC America, Inc. ELW Class II 2000-01-27
K994190 IMPREGUM GARANT L DUOSOFT Espe Dental AG ELW Class II 2000-01-27
K992504 EMS KERMIT (Ems Sa) Electro Medical Systems ELC Class II 2000-01-27
K993784 UNIGRAFT Unicare Biomedical LYC Class II 2000-01-27
K993827 UFI GEL HARD Voco GmbH EBI Class II 2000-01-20
K993869 INTER-OS BONE GENERATOR Inter-Os Technologies, LLC MQN Class II 2000-01-19
K992727 THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM Mds KIF Class II 2000-01-18
K993658 RENAMEL SCULPT Cosmedent, Inc. EBF Class II 2000-01-18
K993659 RENAMEL PACK Cosmedent, Inc. EBF Class II 2000-01-18
K993238 FORTOSS-CEMA Biocomposites, Ltd. LYC Class II 2000-01-14
K994048 PORTABLE LIGHT CURING UNIT Gregory S. Jacob, D.D.S. EBZ Class II 2000-01-13
K994056 ADMIRA Voco GmbH EBF Class II 2000-01-12
K994028 FLIPO XENON CURING LIGHT Lokki EBZ Class II 2000-01-12
K992489 3M TR SYSTEM 3M Company EIH Class II 2000-01-11
K993526 SYNEA - LS LOW-SPEED HANDPIECE A-Dec, Inc. EFB Class I 2000-01-11
K994037 THE 4.5MM DIAMETER BICON DENTAL IMPLANT Bicon, Inc. DZE Class II 2000-01-11
K993973 FUJI II LC CAPSULE GC America, Inc. EBF Class II 2000-01-11
K971732 DENTAL HANDPIECE Pauline M. Nicholls EFB Class I 2000-01-11
K993560 FRIALIT-2 BONE PROFILER Friadent GmbH DZE Class II 2000-01-10
K993897 CERGOGOLD Degussa - Ney Dental, Inc. EIH Class II 2000-01-10
K993493 THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc. DZL Class II 2000-01-07
K993556 LIQUIBAND DENTAL Medlogic Global Corp. EMA Class II 2000-01-03
K994251 KETAC-MOLAR QUICK Espe Dental AG EBF Class II 2000-01-03
K993575 RESOLVE QUICKANCHOR Mitek Products DZL Class II 1999-12-29
K993862 MODUS SAGITTAL SPLIT PLATE The Straumann Co. JEY Class II 1999-12-29
K993932 SOLITAIRE 2 Heraeus Kulzer, Inc. EBF Class II 1999-12-22
K993717 ENIGMA HI-BASE DENTURE BASE MATERIAL Davis Schottlander & Davis, Ltd. EBI Class II 1999-12-22
K993710 MODIFICATION OF PARAPOST CEMENT Coltene/Whaledent, Inc. EMA Class II 1999-12-21
K993381 TONGUE STABILIZER DEVICE University of Otago LRK Class II 1999-12-21
K993716 PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE Harry J. Bosworth Co. EBF Class II 1999-12-21
K980760 KLS-MARTIN MMF SCREW KLS-Martin L.P. DZL Class II 1999-12-21
K993327 TALON ANCHOR SNAP-PAK Mitek Products DZL Class II 1999-12-16
K993602 PRE-VISION FILL Heraeus Kulzer, Inc. EBF Class II 1999-12-15
K991401 ATR 3000, ATR 2000, IMPLANT-PRO Advanced Technology Research (A.T.R.) S.R.P. EFB Class I 1999-12-15
K993783 TETRIC FLOW Ivoclar North America, Inc. EBF Class II 1999-12-13
K993683 PULPDENT UNO-DUO Pulpdent Corp. KLE Class II 1999-12-13
K993572 CERADIUM V NON-PRECIOUS CERAMIC ALLOY Matech, Inc. EJH Class II 1999-12-13
K993475 AUROFLUID M, ALLOY NO. 5315 Metalor Dental USA Corp. EJS Class II 1999-12-09
K993095 FRIALIT-2 SELECT COMPONENTS Friadent GmbH DZE Class II 1999-12-09
K993505 V-DELTA SPECIAL, ALLOY NO. 5154 Metalor Dental USA Corp. EJS Class II 1999-12-08
K993506 PAGALINOR 4 , ALLOY NO. 5440 Metalor Dental USA Corp. EJS Class II 1999-12-08
K993507 V-SUPRAGOLD, ALLOY NO. 5024 Metalor Dental USA Corp. EJT Class II 1999-12-06
K993566 PROMPTFLOW Espe Dental AG EBF Class II 1999-12-06
K993508 V-SUPRA PLUS, ALLOY NO. 5025 Metalor Dental USA Corp. EJT Class II 1999-12-06
K991492 LC COMPOSITE Harry J. Bosworth Co. EFB Class I 1999-12-02
K993474 DELTAPAL, ALLOY NO. 5161 Metalor Dental USA Corp. EJS Class II 1999-12-02
K993013 SURE BOND Miradent Distributing Co., LLC KLE Class II 1999-11-29
K993249 OPC LOW WEAR OPAQUE PORCELAIN Jeneric/Pentron, Inc. EIH Class II 1999-11-29
K992909 HYTAC Espe Dental AG EBF Class II 1999-11-24
K992682 MODUS 2.5 MANDIBULAR RECONSTRUCTION SET Medartis AG JEY Class II 1999-11-24
K992683 MODUS 2.5 MANDIBULAR TRAUMA SET Medartis AG JEY Class II 1999-11-24
K992538 AMORPHOUS DIAMOND COATED SCREW Nobel Biocare Uas, Inc. DZE Class II 1999-11-23
K992330 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics JEY Class II 1999-11-23
K992952 LORENZ DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. MQN Class II 1999-11-19
K992881 HI BOND NON-PRECIOUS CERAMIC ALLOY Matech, Inc. EJH Class II 1999-11-19
K990537 OSTEO-PIN MEMBRANE FIXATION PIN Luitpold Pharmaceuticals, Inc. LYC Class II 1999-11-19

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