meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
1999-02-25

Clearances · page 71 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990155 HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 Kay See Dental Mfg. Co. EMA Class II 1999-02-25
K990225 ENDO ANALYZER, MODEL 8005, MODIFIED Sybron Dental Specialties, Inc. EAT Class II 1999-02-25
K984365 GC UNIFAST TRAD GC America, Inc. EBI Class II 1999-02-25
K984247 ELIPAR TRILIGHT Espe Dental AG EBZ Class II 1999-02-25
K990219 MODIFICATION OF MILLENNIUM Biolase Technology, Inc. MXF Class II 1999-02-24
K984467 FUSICRYL Micro Dental Laboratories EBI Class II 1999-02-24
K984244 ORL-E-92 SURGICAL DRILL SYSTEM Bien Air USA, Inc. EFB Class I 1999-02-23
K984198 WIDE BODY ABUTMENTS Vident DZE Class II 1999-02-18
K984483 A-SOFT RELINER S & C Polymer GmbH EBI Class II 1999-02-18
K982721 BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM Bionx Implants, Inc. JEY Class II 1999-02-17
K984134 NATURA DENTURE TEETH Davis Schottlander & Davis, Ltd. ELM Class II 1999-02-12
K982915 SCI-PHARM DFV VARNISH Scientific Pharmaceuticals, Inc. LBH Class II 1999-02-12
K983104 NORIAN PERIODONTAL/DENTAL CEMENT (PDC) Norian Corp. LYC Class II 1999-02-12
K990078 D-SIGN IV (R&D PROJECT DW265#37) Ivoclar North America, Inc. EJS Class II 1999-02-12
K990077 D-SIGN III (R&D PROJECT DW264#7) Ivoclar North America, Inc. EJS Class II 1999-02-12
K984117 INNOVA TELESCOPIC DISTRACTOR Innova Corp. MQN Class II 1999-02-10
K984030 VIPERSOFT Integra Medical EHD Class II 1999-02-10
K984556 SCICAN CLASSIC Scholly Fiberoptic GmbH EIA Class I 1999-02-09
K981679 TCM 3000 AND TCM ENDO NOUVAG AG EFB Class I 1999-02-09
K983106 1ST IMPRESSION Den-Mat Corp. ELW Class II 1999-02-09
K984128 ENIGMA DENTURE TEETH Davis Schottlander & Davis, Ltd. ELM Class II 1999-02-09
K984609 ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III Lite Specialty Metal Works, Inc. EIA Class I 1999-02-09
K984097 DC-CORE S & C Polymer GmbH EBF Class II 1999-02-09
K973289 RE NU Pacific Rim Dental, Inc. EJR Class I 1999-02-09
K981862 RESIN 4 Harry J. Bosworth Co. EBI Class II 1999-02-09
K984037 CORE-IDE Roydent Dental Products, Inc. EBD Class II 1999-02-04
K984505 MIRACLE MIX POWDER/LIQUID GC America, Inc. EMA Class II 1999-02-04
K984230 OSTEO-MESH TM-300 Osteogenics Biomedical, Inc. JEY Class II 1999-02-04
K990040 CLEARFIL SE BOND Kuraray Co. KLE Class II 1999-02-04
K983885 BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES Howmedica, Inc. JEY Class II 1999-01-29
K983966 NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN Dentsply Intl. EJR Class I 1999-01-29
K983029 POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 Tpc Advanced Technology, Inc. ELC Class II 1999-01-29
K982488 BICON BONE SCREW SYSTEM Bicon, Inc. DZE Class II 1999-01-26
K984013 PLANMECA INTRACAM STATION Planmeca Oy EIA Class I 1999-01-26
K983809 KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR KLS-Martin L.P. MQN Class II 1999-01-26
K981954 VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS Healthline Implants, Inc. NRQ Class II 1999-01-25
K984362 ENLIGHT LV Sybron Dental Specialties, Inc. DYH Class II 1999-01-21
K984217 ENLIGHT-2 Sybron Dental Specialties, Inc. DYH Class II 1999-01-20
K983727 BIOSONIC ULTRASONIC SCALER SYSTEM Coltene/Whaledent, Inc. ELC Class II 1999-01-20
K984484 LC MICROHYBRID S & C Polymer GmbH EBF Class II 1999-01-20
K983739 OPTUM, INTRAORAL CAMERA SYSTEM Camsight, Inc. EIA Class I 1999-01-19
K984451 D-SIGN I (R&D PROJECT DW263 #24) Ivoclar North America, Inc. EJS Class II 1999-01-19
K984524 AZTECH 70 Villa Sistemi Medicali S.P.A. EHD Class II 1999-01-14
K983683 UNIK TONGUE CLEANER Unik Products, Inc. LCN Class I 1999-01-14
K984387 R-30 AESTHETIC RESTORATIVE Dentsply Intl. EBF Class II 1999-01-13
K984140 MAINBOND A J.F. Jelenko & Co., Inc. EJT Class II 1999-01-13
K983661 BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES Belmont Equipment Corp. EIA Class I 1999-01-12
K981997 POSI-STOP/POSI-TRAC SYSTEM The Dental Medical Device Co., LLC DZE Class II 1999-01-12
K983625 S555 INTRAORAL DENTAL CAMERA Sopro EIA Class I 1999-01-11
K983563 IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I Imcor DZE Class II 1999-01-11
K984341 STERNVANTAGE VARNISH LC, MODEL 221001 Sterngold/Implamed EBI Class II 1999-01-08
K984340 STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 Sterngold/Implamed EMA Class II 1999-01-08
K984246 PROMPT L-POP Espe Dental AG KLE Class II 1999-01-08
K984248 PROCEM Espe Dental AG EMA Class II 1999-01-08
K983574 STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS Dentalez Group EGS Class I 1999-01-08
K983735 PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE Pall Medical EIA Class I 1999-01-07
K983547 PROTECH PLUS Protech, Inc. EBI Class II 1999-01-07
K983558 ACETAL DENTAL/PREFORMED CLASP Dentamax, Inc. EHP Class I 1999-01-07
K983347 OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 1999-01-06
K983267 DIGORA FOR WINDOWS 2.0 Orion Corporation Soredex MUH Class II 1998-12-30
K984164 JELBOND NP Jelenko Co. EJH Class II 1998-12-29
K983535 THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 Hans Hermann GmbH JEY Class II 1998-12-29
K983528 MICRO DYNAMIC MESH Howmedica Corp. JEY Class II 1998-12-23
K983374 AGATHA-A-H2010 Midian Intl. EFS Class I 1998-12-23
K983470 SUPER PORCELAIN STAIN- PURE WHITE Noritake Co., Inc. EIH Class II 1998-12-22
K984112 ADVENT Bisco, Inc. EBF Class II 1998-12-22
K983477 SUPER SEAL Phoenix Dental, Inc. EJK Class II 1998-12-22
K983413 MODEL MS-1 HANDPIECE Parkell, Inc. EKX Class I 1998-12-21
K983485 SYNTHES 1.3 MM SELF-DRILLING SCREW Synthes (Usa) DZL Class II 1998-12-21
K983731 PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE Pall Medical EIA Class I 1998-12-21
K983305 SCI-PHARM DESENSITIZING VARNISH Scientific Pharmaceuticals, Inc. LBH Class II 1998-12-17
K984044 QUADRANT POSTERIOR DENSE Cavex Holland BV EBF Class II 1998-12-16
K983414 EVERBOND Espe Dental AG KLE Class II 1998-12-16
K983876 MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind EBI Class II 1998-12-16
K983242 SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH EIA Class I 1998-12-11
K983227 POWER BLOCK Kreativ, Inc. EIE Class I 1998-12-11
K983183 GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P Bien Air USA, Inc. EFB Class I 1998-12-10
K983752 ALUMINA-ZINC OXIDE POWDERS F AND R Harry J. Bosworth Co. EMA Class II 1998-12-10
K981972 GREEN-OR DENTIN DESENSITIZER Centrix, Inc. LBH Class II 1998-12-07
K984042 QUADRANT CORE LC Cavex Holland BV EBF Class II 1998-12-04
K984043 QUADRANT TOTAL ETCH Cavex Holland BV EBF Class II 1998-12-04
K984041 QUADRANT UNIVERSAL LC Cavex Holland BV EBF Class II 1998-12-04
K981171 ERADIC-ALL Theratechnologies, Inc. EIA Class I 1998-12-02
K981881 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING Doctor'S Research Group, Inc. DZL Class II 1998-12-02
K983847 MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT Germiphene Corp. EIA Class I 1998-12-01
K983668 MODIFICATION OF PQ1 Ultradent Products, Inc. KLE Class II 1998-11-30
K983751 QUADRANT UNICHEM Cavex Holland BV EBF Class II 1998-11-30
K983515 KLS INTRAORAL VERTICAL DISTRACTOR KLS-Martin L.P. MQN Class II 1998-11-30
K983549 QUADRANT ANTERIOR SHINE Cavex Holland BV EBF Class II 1998-11-23
K974738 ASTRA TECH IMPLANT DENTAL SYSTEM Astra Tech, Inc. DZE Class II 1998-11-19
K983168 AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 Ora Innovations, Inc. EFB Class I 1998-11-18
K983453 PROCERA ALLCERAM FUSING MATERIAL Nobel Biocare Uas, Inc. EIH Class II 1998-11-18
K983087 BREATHTIQUE TONGUE SCRAPER Custom Medical Arts, Inc. LCN Class I 1998-11-18
K983370 PRODIGY- 3 Sybron Dental Specialties, Inc. EBF Class II 1998-11-18
K983545 QUADRANT UNIBOND Cavex Holland BV KLE Class II 1998-11-18
K983361 PANAVIA F Kuraray America, Inc. EMA Class II 1998-11-13
K983786 STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION Sterngold/Implamed DZE Class II 1998-11-13
K983357 MUCOPREN SOFT RELINING SYSTEM Roydent Dental Products, Inc. EBI Class II 1998-11-13
K982906 LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. MQN Class II 1998-11-12
K980800 LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL Cosmedent, Inc. EBF Class II 1998-11-09

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