meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2006-02-22

Clearances · page 51 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K053493 BERRY FRUITY TEETHER Evenflo Company, Inc. KKO Class II 2006-02-22
K053125 PROCERA BRIDGE ZIRCONIA Nobel Biocare AB NHA Class II 2006-02-22
K052823 IMPLANTIUM ABUTMENTS Dentium, Inc. NHA Class II 2006-02-21
K053374 OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) Ossacur AG LYC Class II 2006-02-21
K053558 CEPH, MODEL 4900 Schick Technologies, Inc. MUH Class II 2006-02-17
K051636 CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES Altatec GmbH NHA Class II 2006-02-17
K060293 TEMPORARY CROWN AND BRIDGE MATERIAL Dentsply International, Inc. EBG Class II 2006-02-17
K051931 AXCEL Tri Dental Innovators EBF Class II 2006-02-17
K050956 TBR IDEA CONIC/CONIC Sudimplant SA DZE Class II 2006-02-16
K053391 X-TRA FIL Voco GmbH EBF Class II 2006-02-15
K053099 BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS BioHorizons Implant Systems, Inc. NHA Class II 2006-02-14
K053387 PERIOGLAS BONE GRAFT PARTICULATE Novabone Products, LLC LYC Class II 2006-02-14
K053602 PROCERA SOFTWARE, MODEL 33145 Nobel Biocare AB NHA Class II 2006-02-10
K060179 BIO-RAY SDX DIGITAL X-RAY SYSTEM Sigma Biomedics, Inc. MUH Class II 2006-02-08
K052281 EMBRACE WETBOND CLEAR SEALANT Pulpdent Corporation EBC Class II 2006-02-08
K060079 KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM Eastman Kodak Company MUH Class II 2006-02-08
K060080 DIAGNODENT 2190 WITH PERIODONTAL PROBE Kavo Dental Corporation NTK Class II 2006-02-08
K053565 TEMPBOND CLEAR WITH TRICLOSAN Sybron Dental Specialties, Inc. EMA Class II 2006-02-03
K060062 STRAUMANN ORTHOSYSTEM Institut Straumann AG OAT Class II 2006-02-03
K060149 SUNIPAN IMAGING SYSTEM & ACCESSORIES Suni Medical Imaging, Inc. MUH Class II 2006-02-03
K053170 PREFORMANCE POSTS Implant Innovations, Inc. NHA Class II 2006-02-01
K053178 SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS Hu-Friedy Mfg. Co., Inc. ELC Class II 2006-02-01
K053103 INTERFACE Apex Dental Materials, Inc. KLE Class II 2006-02-01
K052654 KLOCKNER DENTAL IMPLANT, MODEL S3M SOADCO, S.L. DZE Class II 2006-01-30
K052951 ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. DZE Class II 2006-01-27
K053091 PROCERA IMPLANT BRIDGE ZIRCONIA Nobel Biocare AB NHA Class II 2006-01-27
K053516 MUCOHARD Parkell, Inc. EBI Class II 2006-01-26
K053379 RELI-ON ONE STEP, ORTHODONTIC ADHESIVE Classone Orthodontics, Inc. DYH Class II 2006-01-25
K053328 BIOSPLINT SPLINTING RIBBON Satelec EBI Class II 2006-01-25
K053643 STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 Lifecore Biomedical, Inc. NHA Class II 2006-01-23
K052997 ZIMMER DENTAL ONE-PIECE IMPLANT Zimmer Dental, Inc. DZE Class II 2006-01-23
K053022 SYNTHES (USA) CHRONOS-BETA-TCP Synthes (Usa) LYC Class II 2006-01-23
K052822 DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 Thunder Tiger Corp. EFB Class I 2006-01-20
K053438 GLASS CERAMICS 3M Espe AG Dental Products EIH Class II 2006-01-18
K052741 IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES W&H Dentalwerk Buermoos GmbH EBW Class I 2006-01-13
K053427 FRESH, DENTAL IMPRESSION MATERIAL Exacta Dental Products, Inc. ELW Class II 2006-01-13
K052710 VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, Vident EIH Class II 2006-01-13
K053221 CDMX-H Camsight Co., Inc. MUH Class II 2006-01-12
K052369 EXFEEL IMPLANT SYSTEM Megagen Co., Ltd. DZE Class II 2006-01-10
K052820 PARAPOST PARACORE AUTOMIX 5ML Coltene/Whaledent AG EBF Class II 2006-01-09
K053242 PITT-EASY DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. DZE Class II 2006-01-06
K053220 VERAVIEW IC 5, MODEL XDP1 J. Morita USA, Inc. MUH Class II 2006-01-06
K051188 GRAFTON DBM Osteotech, Inc. NUN Class II 2006-01-03
K053065 FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) Bryan Keropian Dds LQZ Class II 2006-01-03
K051933 EXPASYL POWER APPLICATOR Sybron Dental Specialties, Inc. ELW Class II 2006-01-03
K052272 STRAUMANN COMPUTER AIDED RESTORATION SERVICE Straumann USA NHA Class II 2006-01-03
K052862 FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) Bryan Keropian Dds LQZ Class II 2005-12-30
K052885 ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 Nobel Biocare USA, LLC NHA Class II 2005-12-23
K052471 HDC SPIDER SCREW Hdc S.R.L. DZE Class II 2005-12-23
K052733 ALMITECH INC. DENTAL IMPLANT SYSTEM Almitech, Inc. DZE Class II 2005-12-22
K052553 NITOM LOCKING FACEBOW Russell Samuels Orthodontic Design DZB Class II 2005-12-22
K053055 ORTHODONTIC POLYMER COMPOSITE BRACKET Gestenco International AB DYW Class II 2005-12-22
K052780 DENTAPLAST HOT, MODEL 16-XXX Bredent-Products For the Dental Technician Laborat EBI Class II 2005-12-21
K052700 PANA-SPRAY Nsk America Corp. EFB Class I 2005-12-20
K053089 ASCENT PIT & FISSURE SEALANT CAO Group, Inc. EBC Class II 2005-12-20
K052779 BRECOMP Bredent-Products For the Dental Technician Laborat EBF Class II 2005-12-20
K052263 MULTIPLE (TOOTH DESENSITIZER) Cosmedent, Inc. LBH Class II 2005-12-16
K053392 FUTURABOND NR SINGLE DOSE Voco GmbH KLE Class II 2005-12-15
K052531 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER Fu Hong Industries , Ltd. KKO Class II 2005-12-14
K052622 MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT Macan Engineering Co. EKZ Class II 2005-12-09
K052781 BREFORMANCE Bredent-Products For the Dental Technician Laborat EBG Class II 2005-12-09
K052490 ENDOSSEOUS DENTAL IMPLANT SYSTEM Northern Implants, LLC DZE Class II 2005-12-08
K053152 BIOHORIZONS SINGLE-STAGE IMPLANT BioHorizons Implant Systems, Inc. DZE Class II 2005-12-02
K052477 DAMON 3 MODIFIED Ormco Corp. DYW Class II 2005-11-30
K042707 GRAFTON PLUS DBM PASTE Osteotech, Inc. NUN Class II 2005-11-30
K052455 IMPRESSIX Cavex Holland BV ELW Class II 2005-11-23
K052304 SUPER PORCELAIN EX-3 PRESS Noritake Co., Inc. EIH Class II 2005-11-23
K052033 VINTAGE ZR Shofu Dental Corp. EIH Class II 2005-11-18
K052699 VERSA-LINK PORCELAIN BONDING SYSTEM Sultan Chemists, Inc. KLE Class II 2005-11-16
K052518 PIEZOSURGERY Piezosurgery S.R.L. ELC Class II 2005-11-16
K053014 POLY SILOXANE IMPRESSION MATERIAL Clinician'S Choice Dental Products, Inc. ELW Class II 2005-11-15
K053114 SILVERFIL Dunia Perwira Manufacturing Sdn. Bhd. EJJ Class II 2005-11-15
K053040 PARACEM UNIVERSAL DC Coltene/Whaledent AG EMA Class II 2005-11-09
K053018 POLY SILOXANE IMPRESSION MATERIAL Millennium Dental International, Inc. ELW Class II 2005-11-08
K053030 J. MORITA AZ ULTRASONIC SYSTEM J. Morita USA, Inc. ELC Class II 2005-11-07
K050571 ABSOLUTE AMERICA Eurodent S.P.A. EIA Class I 2005-11-02
K052470 F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT Shanghai Fimet Medical Instrument Co., Ltd. EIA Class I 2005-11-01
K052370 CP BRACKET SYSTEM Dentsply International DYW Class II 2005-11-01
K052106 SIMILE FLOW Pentron Clinical Technologies EBF Class II 2005-10-31
K052105 WATER FILLED TEETHER Royal Industries (Thailand) Public Co. , Ltd. KKO Class II 2005-10-31
K052028 BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) Bonart Co., Ltd. ELC Class II 2005-10-28
K051871 STOMA BONE SCREW Storz AM Mark GmbH DZL Class II 2005-10-27
K052714 RAVE COMPOSITE BRACKET FDA Agents DYW Class II 2005-10-26
K052073 FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 Schutz-Dental GmbH EBI Class II 2005-10-26
K052543 HERACERAM ZIRKONIA Heraeus Kulzer, Inc. EIH Class II 2005-10-25
K052061 MODUS IMF SCREWS 2.0 Medartis, Inc. DZE Class II 2005-10-21
K052501 MULTIPLE RESIN TOOTH BONDING AGENT Cosmedent, Inc. KLE Class II 2005-10-21
K051909 DIAGNODENT Kavo America NBL Class II 2005-10-21
K052349 AVANTE LED CURING UNIT, MODEL N44 Pentron Clinical Technologies EBZ Class II 2005-10-21
K052648 MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS Implant Innovations, Inc. NHA Class II 2005-10-20
K052409 SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL Sultan Chemists, Inc. ELW Class II 2005-10-20
K052462 G-COAT GC America, Inc. EBD Class II 2005-10-20
K051501 ZIRACE Acucera, Inc. NHA Class II 2005-10-19
K052040 QUICKSMILE Cosmetic Dental Materials, Inc. EEG Class I 2005-10-18
K052189 REVENEER CERAMIC REPAIR SYSTEM Schutz-Dental GmbH KLE Class II 2005-10-17
K051705 IPS E.MAX CAD/IPS E.MAX ZIRCAD Ivoclar Vivadent, Inc. EIH Class II 2005-10-14
K052070 ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA Atlantis Components, Inc. NHA Class II 2005-10-14
K052463 PROMETAL HN86 Prometal Technologies EJT Class II 2005-10-14
K050970 MILO DENTAL IMPLANT SYSTEM Intra-Lock International DZE Class II 2005-10-14
K052600 ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) Zimmer Dental, Inc. NHA Class II 2005-10-13

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