meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
2010-08-17

Clearances · page 39 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100245 HS/HG PROSTHETIC SYSTEM Osstem Implant Co., Ltd. NHA Class II 2010-08-17
K101004 ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. NHA Class II 2010-08-16
K101029 KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH Huge Dental Material Co., Ltd. ELM Class II 2010-08-16
K100389 HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT Handpiece Headquarters EFB Class I 2010-08-12
K100156 COLLAGEN DENTAL MEMBRANE V Collagen Matrix, Inc. NPL Class II 2010-08-11
K102128 VITABLOCS Vita Zahnfabrik H.Rauter GmbH & Co. EIH Class II 2010-08-11
K101207 NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S DZE Class II 2010-08-02
K093000 EMS PIEZON MASTER 700 E.M.S Electro Medical Systems S.A ELC Class II 2010-07-30
K101423 OPTIBOND XTR Kerr Corporation KLE Class II 2010-07-30
K100411 VARIOUS DENTAL IMPLANTS Grundy Advanced Biomedical Systems, LLC DZE Class II 2010-07-28
K100536 TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE 3M Unitek DYH Class II 2010-07-27
K101172 RDT3 HANDPIECE HEAD MODEL RDT3 Redent Nova, Ltd. EFA Class I 2010-07-27
K093266 MAM COOLER Mam International AG KKO Class II 2010-07-27
K092261 DEFCON TSA/TSH DENTAL IMPLANT SYSTEM Impladent, S.L. DZE Class II 2010-07-23
K100247 DETAX IMPLANTLINK SEMI Detax GmbH & Co. KG EMA Class II 2010-07-23
K082573 SARGON NON-EXPANDABLE DENTAL IMPLANT Sargon Ent., Inc. DZE Class II 2010-07-21
K092329 SOPIX 2 Sopro MUH Class II 2010-07-20
K100752 PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) Ultradent Products, Inc. KLE Class II 2010-07-16
K101140 DENTLIGHT ORAL EXAM LIGHT KIT Dentlight, Inc. NXV Class II 2010-07-15
K100600 PROSTHODONTIC SCREWDRIVER , MODEL IA-400 W&H Dentalwerk Buermoos GmbH EKX Class I 2010-07-09
K100647 A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM A-Dec, Inc. ELC Class II 2010-07-09
K100511 COTEC DENTAL IMPLANT SYSTEM Cotec Implant Co., Ltd. DZE Class II 2010-07-09
K101060 SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM Siesta Medical, Inc. ORY Class II 2010-07-08
K090950 BONE PLUS BCP Megagen Implant Co., Ltd. LYC Class II 2010-07-02
K101612 ZEN CORDLESS PROPHY SYSTEM Discus Dental, LLC EKX Class I 2010-06-30
K091807 MEDPOR FIXATION SYSTEM Porex Surgical, Inc. JEY Class II 2010-06-28
K100902 AEDIS(TM) Embed Technology, LLC DZE Class II 2010-06-24
K093643 MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS Nobel Biocare AB NHA Class II 2010-06-24
K092917 STERN'S S250 NORDAM Cefla S.C. EIA Class I 2010-06-24
K101481 BIOMERS TRANSLUCENT ORTHODONTIC BRACKET Biomers Products, LLC NJM Class II 2010-06-23
K092781 MAM TWISTER Mam International AG KKO Class II 2010-06-23
K093407 ZQUIET MOUTHPIECE Sleeping Well, LLC LRK Class II 2010-06-22
K090081 TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS Talladium Espana, SL NHA Class II 2010-06-22
K100908 UNICEM HM 3M Espe AG Dental Products EMA Class II 2010-06-22
K100781 OBSIDIAN CERAMIC BLOCKS Prismatik Dentalcraft, Inc. EIH Class II 2010-06-21
K100539 PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE Preventive Technologies, Inc. EJR Class I 2010-06-17
K092194 POLYBONE DENTAL Kyung Won Medical Co., Ltd. LYC Class II 2010-06-16
K093340 PASR/QUIETNITE Exact Supplies , Ltd. LRK Class II 2010-06-11
K101044 RETRIEVE IMPLANT CEMENT Parkell, Inc. EMA Class II 2010-06-10
K093975 SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 Pan Global Implant NHA Class II 2010-06-04
K093630 BIODENTA DENTAL IMPLANT SYSTEM Biodenta Swiss AG DZE Class II 2010-06-03
K100833 SYLE SMARTIP Osspray, Ltd. EFB Class I 2010-06-03
K100756 MALTA 3M Espe AG Dental Products EMA Class II 2010-06-02
K100606 VATEA ENDONTIC IRRIGATION SYSTEM Redent Nova, Ltd. NYL Class I 2010-05-28
K100150 CERAMICS2IN1 Biodenta Swiss AG EIH Class II 2010-05-25
K093390 HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 Depuy Spine, Inc. LYC Class II 2010-05-25
K100232 LUMINESSE ZR BLANKS Talladium, Inc. EIH Class II 2010-05-21
K100503 PULPDENT COPAL VARNISH WITH FLUORIDE Pulpdent Corporation LBH Class II 2010-05-12
K101215 NUANCE Discus Dental, LLC EBF Class II 2010-05-12
K093590 PLANMECA PROMAX 3D MAX Planmeca Oy MUH Class II 2010-05-12
K100235 FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE 3M Company EBF Class II 2010-05-12
K091255 MINXRAY, MODEL: BPD60 Minxray, Inc. EHD Class II 2010-05-12
K093710 THE MOSES APPLIANCE Allen J. Moses, Dds, Ltd. LRK Class II 2010-05-12
K100160 ZZOMA POSITIONAL SLEEPER MODEL 001 Sleep Specialists, LLC MYB Class II 2010-05-11
K092507 ZIT-Z Ziterion DZE Class II 2010-05-11
K100182 SALVIN DENTAL SPECIALTIES FIXATION SCREW Salvin Dental Specialties, Inc. DZL Class II 2010-05-10
K091812 FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS Frontier Devices, Inc. JEY Class II 2010-05-07
K100347 OPTIBOND SE Kerr Corporation KLE Class II 2010-04-30
K100301 OPAL BOND FLOW Ultradent Products, Inc. DYH Class II 2010-04-29
K092171 VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM Genoray Co., Ltd. MUH Class II 2010-04-26
K093478 KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM Trophy MUH Class II 2010-04-26
K092542 M Mediscitec, Inc. DZE Class II 2010-04-23
K093705 FUORECAM Therapeutic Technologies, Inc. NBL Class II 2010-04-23
K093889 MODIFICATION TO: HG III ULTRA WIDE SYSTEM Hiossen, Inc. DZE Class II 2010-04-22
K093971 DENTAL HANDPIECE North West Medical Instrument (Group) Co., Ltd. EFB Class I 2010-04-22
K093871 PERIOPHIL B-TCP Cytophil, Inc. LYC Class II 2010-04-22
K093780 ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT Astra Tech, Inc. NHA Class II 2010-04-16
K090436 AIRWAYEASE MAS Orthoplant Dental Lab LRK Class II 2010-04-16
K093014 AMERICAN DENTAL PRODUCTS SE BONDEASY American Dental Products, Inc. KLE Class II 2010-04-16
K100145 A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 A&E Bioceramic Co., Ltd. EIH Class II 2010-04-13
K094007 UNICEM 3M Espe AG Dental Products EMA Class II 2010-04-08
K100250 XCERAM Xceramusa EIH Class II 2010-04-08
K093341 CENTURY MODEL 105C Sybron Dental Specialties, Inc. EFB Class I 2010-04-05
K092530 SPRYTIE, MODELS ST001, ST002 AND ST003 Russell B. Walther DZK Class II 2010-04-02
K093321 BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 2010-04-02
K100633 INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 D B Orthodontics, Ltd. OAT Class II 2010-04-01
K100671 NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT Novabone Products, LLC LYC Class II 2010-03-30
K100401 SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM Hu-Friedy Mfg. Co., Inc. ELC Class II 2010-03-30
K100062 INFILTRATION KIT Dmg USA, Inc. EBC Class II 2010-03-26
K100510 CERAMIR CROWN & BRIDGE Doxa AB EMA Class II 2010-03-25
K100317 DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO VATECH Co., Ltd. MUH Class II 2010-03-24
K094006 OPAL BOND MV Ultradent Products, Inc. DYH Class II 2010-03-23
K093240 BELRAY II Takara Belmont Corp. EHD Class II 2010-03-22
K100083 ESTHETICA Kerr Corporation EBF Class II 2010-03-19
K091120 MEDPOR CONTAIN IMPLANT Porex Surgical, Inc. NPK Class II 2010-03-19
K092428 BIO-OSS COLLAGEN Ed. Geistlich Soehne AG Fuer Chemische Industrie NPM Class II 2010-03-18
K093122 MBCP+ Biomatlante LYC Class II 2010-03-15
K093571 ZR DENTAL BLOCK Ams Co., Ltd. EIH Class II 2010-03-12
K092141 VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 3M Espe Dental Products LBH Class II 2010-03-10
K093744 EXCITE F AND EXCITE DSC Ivoclar Vivadent, Inc. KLE Class II 2010-03-10
K093620 PULPDENT FLUORIDE VARNISH Pulpdent Corporation LBH Class II 2010-03-10
K093708 TELIO CAD Ivoclar Vivadent, Inc. EBG Class II 2010-03-10
K093575 GLUMA DESENSITIZER POWER GEL Heraeus Kulzer, LLC LBH Class II 2010-03-05
K100328 CLEARFIL MAJETY POSTERIOR Kuraray Medical, Inc. EBF Class II 2010-03-05
K093380 MIZZY EXPRESS Mycone Dental Supply Co., Inc. EBG Class II 2010-03-05
K092857 VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS Whip-Mix Corp. NHA Class II 2010-03-04
K093615 SPI DENTAL IMPLANT, ELEMENT Thommen Medical AG DZE Class II 2010-03-04
K093559 VINTAGE MP Shofu Dental Corp. EIH Class II 2010-03-03
K091208 GS III SYSTEM Osstem Implant Co., Ltd. DZE Class II 2010-03-03
K093894 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE Anthogyr EFA Class I 2010-03-03

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