meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
2010-03-03

Clearances · page 40 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100413 TEMP IT Spident Co., Ltd. EBF Class II 2010-03-03
K093719 PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# Osteogenics Biomedical, Inc. DZL Class II 2010-03-01
K092494 GEL FILLED GUM SOOTHER Luv N' Care, Ltd. KKO Class II 2010-03-01
K083876 SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT Cendres & Metaux SA NHA Class II 2010-02-26
K093751 CL-DC20, CL-DC21 Good Doctors Co., Ltd. EBZ Class II 2010-02-24
K093748 DD BIO Z AND DD BIO Z - TRANSPA Dental Direkt of Amerika UG (Haftungsbeschraenkt) EIH Class II 2010-02-24
K091678 HG II SHORT FIXTURE SYSTEM Osstem Implant Co., Ltd. DZE Class II 2010-02-18
K093470 CORE-FLO D/C Bisco, Inc. EBF Class II 2010-02-17
K100290 ESTEMP NE Spident Co., Ltd. EMA Class II 2010-02-17
K093208 SIMPLISEAL Discus Dental, LLC KIF Class II 2010-02-12
K093338 SELF ADHESIVE COMPOSITE LUTING CEMENT Dmg USA, Inc. EMA Class II 2010-02-12
K093027 STRAUMANN RC TEMPORARY ABUTMENTS Straumann USA DZE Class II 2010-02-12
K100192 STRONG DENTAL HANDPIECES Saeshin Precision Co., Ltd. EGS Class I 2010-02-04
K093059 SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT Classone Orthodontics, Inc. EBC Class II 2010-02-04
K092176 TAKE 1 ADVANCED RIGID TRAY Kerr Corporation ELW Class II 2010-01-28
K093560 UPCERA ZIRCONIA BLANKS Shenyang Upcera Co., Ltd. EIH Class II 2010-01-28
K093331 SR PHONARES NHC Ivoclar Vivadent, Inc. ELM Class II 2010-01-28
K093484 PREMISE FLOWABLE MODIFIED Kerr Corporation EBF Class II 2010-01-27
K093464 RAPIDSORB PLUS SCREW SYSTEM Synthes (Usa) DZL Class II 2010-01-25
K091387 BTI DENTAL IMPLANT 5.5-6.5 B.T.I. Biotechnology Institute, Sl. DZE Class II 2010-01-22
K093370 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER Fu Hong Industries , Ltd. KKO Class II 2010-01-21
K093587 DENTAL MERCURY Dmg USA, Inc. ELY Class II 2010-01-21
K092743 THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker Craniomaxillofacial JEY Class II 2010-01-15
K083811 W&H HANDPIECE ANESTO, MODEL: RA-5 W&H Dentalwerk Buermoos GmbH EGM Class II 2010-01-14
K093518 ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM Ace Surgical Supply Co., Inc. DZE Class II 2010-01-14
K092933 SAF (SELF ADJUSTING FILE) Redent-Nova , Ltd. EFB Class I 2010-01-14
K092583 SOPROLIFE Sopro NBL Class II 2010-01-13
K092942 VITAL SLEEP The Snore Reliever Company, LLC LRK Class II 2010-01-13
K091182 CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 Champions Implants GmbH DZE Class II 2010-01-07
K092833 ENDOMAX CORDLESS ENDODONTIC HANDPIECE Dentamerica EKX Class I 2010-01-07
K092772 PORTABLE X-RAY SYSTEM, MODEL HAND-RAY Hanjin Digi-X Co., Ltd. EHD Class II 2010-01-06
K092555 UNO NARROW IMPLANT Mis Implants Technologies , Ltd. DZE Class II 2010-01-05
K082249 MORPHEUS Meibach Tech Ltda EJI Class II 2009-12-31
K092087 MEDTRONIC DENTAL TCP Medtronic Sofamor Danek USA, Inc. LYC Class II 2009-12-30
K092855 MILTEX MEMBRANE TACK KIT Miltex, Inc. DZL Class II 2009-12-29
K091227 PIEZOSURGERY 3; OSSTEM PIEZO Piezosurgery S.R.L. DZI Class II 2009-12-29
K093072 STARCARE HANDPIECE MAINTENANCE UNIT Dentalez, Inc. EFB Class I 2009-12-28
K092674 SIMPLER TOADSTOOL MINI IMPLANT Pan Global Implant DZE Class II 2009-12-28
K091729 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE Etex Corp. LYC Class II 2009-12-23
K093483 ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT Astra Tech, Inc. NHA Class II 2009-12-22
K093019 ENAMELITE ACRYSEAL SPRAY SEALANT Enamelite, LLC EBD Class II 2009-12-22
K091701 STRAUMANN MODIFIED DENTAL ABUTMENT Institut Straumann AG NHA Class II 2009-12-22
K092788 PERIOPHIL BIPHASIC Cytophil, Inc. LYC Class II 2009-12-18
K093113 ETKON ES1, MODEL 019.0001, ETKON VISUAL, STRAUMANN CADCAM ABUTMENT Institut Straumann AG NHA Class II 2009-12-18
K092910 FLUID-FILLED TEETHER Qualiman Industrial Co., Ltd. KKO Class II 2009-12-18
K093084 ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP Rolence Ent., Inc. EFB Class I 2009-12-16
K092912 STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 Danville Materials, Inc. EBF Class II 2009-12-16
K090931 CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR W&H Dentalwerk Buermoos GmbH EKX Class I 2009-12-15
K092214 CHIROPRO L SYSTEM Bien-Air Dental, SA EBW Class I 2009-12-15
K090598 CARIESCAN PRO Cariescan , Ltd. NBL Class II 2009-12-15
K092814 STRAUMANN DENTAL ABUTMENTS Straumann Manufacturing, Inc. NHA Class II 2009-12-15
K093164 3.25 SPLINE TWIST IMPLANT, HA COATED Zimmer Dental, Inc. DZE Class II 2009-12-15
K092943 ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE Arnold Tuber Industries EJI Class II 2009-12-11
K092417 INSIGHT ULTRASONIC INSERTS Discus Dental, LLC ELC Class II 2009-12-11
K091331 PIEZOTOME 2 Satelec DZI Class II 2009-12-11
K091233 SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES Synthes (Usa) JEY Class II 2009-12-11
K090794 OSTEOTAPE Impladent , Ltd. NPM Class II 2009-12-10
K083372 ARROWBONE-A, ARROWBONE-B Brainbase Corporation LYC Class II 2009-12-08
K091051 BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM Tita-Link DZE Class II 2009-12-08
K092951 STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS Mectron S.P.A. EBZ Class II 2009-12-07
K091198 LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING Allied Hill Enterprises, Ltd. KKO Class II 2009-12-07
K093446 VITA VMK MASTER Vita Zahnfabrik H. Rauter GmbH & Co. Kg. EIH Class II 2009-12-03
K090526 MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR E-Woo Technology MUH Class II 2009-12-02
K092614 X-SMART EASY Dentsply Interntional EKX Class I 2009-12-02
K092341 LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION Biomet 3i, Inc. NHA Class II 2009-11-30
K093453 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. EAP Class II 2009-11-30
K092567 MODIFICATION TO UNIGRAFT Unicare Biomedical, Inc. LYC Class II 2009-11-25
K093352 HG III FIXTURE SYSTEM Hiossen, Inc. DZE Class II 2009-11-24
K092231 GEBDI TRIBOS 501 Gebdi Dental-Products GmbH ELM Class II 2009-11-24
K092591 ORTHOPANTOMOGRAPH OP30 Instrumentarium Dental, Palodex Group OY MUH Class II 2009-11-20
K092730 COSMEDENT BRUSHABLE COMPOSITE Cosmedent, Inc. EBF Class II 2009-11-20
K092501 LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL Novocol, Inc. EBF Class II 2009-11-12
K092434 STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM Sterngold DZE Class II 2009-11-10
K092446 INTRA LUX HEAD 3 LDSY Kaltenbach & Voigt GmbH & Co. EFA Class I 2009-11-03
K092377 PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S Zimmer Dental, Inc. NHA Class II 2009-11-03
K091192 KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX Kensey Nash Corp. NPL Class II 2009-11-02
K091913 HI TECH IMPLANT, HT PHYSIO IMPLANT By Dental Srl EKX Class I 2009-10-30
K092251 BIODENTINE Septodont KIF Class II 2009-10-30
K091512 BUILD-IT LIGHT CURE Pentron Clinical Technologies EBF Class II 2009-10-30
K093221 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II Dentsply Intl., Inc. DYH Class II 2009-10-30
K092547 DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX Dentimax MUH Class II 2009-10-30
K092403 TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 Zimmer Dental, Inc. NHA Class II 2009-10-30
K090055 LOW & HIGH SPEED KIT Dpm USA Corp. EFA Class I 2009-10-27
K092281 CLEARFIL MAJESTY POSTERIOR PLT Kuraray Medical, Inc. EBF Class II 2009-10-27
K082207 ORTHOCAD IQ Cadent, Inc. DYW Class II 2009-10-23
K092630 ZIROX Zencera, Inc. EIH Class II 2009-10-22
K092616 ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 CAO Group, Inc. KLE Class II 2009-10-21
K092289 EMS AIR-FLOW HANDY PERIO E.M.S Electro Medical Systems S.A EFB Class I 2009-10-20
K091848 NOBEL/PROCERA IMPLANT BRIDGE Nobel Biocare AB NHA Class II 2009-10-16
K091065 AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 J. Morita USA, Inc. EFB Class I 2009-10-16
K092035 BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION Bicon, LLC DZE Class II 2009-10-15
K091091 SONICFILL 2010 Sybron Dental Specialties, Inc. EBF Class II 2009-10-14
K092513 RAINBOW BLOCK Genoss Co., Ltd. EIH Class II 2009-10-09
K092103 DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH Co., Ltd. EHD Class II 2009-10-09
K091613 TAKE 1 Kerr Corp. ELW Class II 2009-10-07
K092112 BTI DENTAL IMPLANT TINY 2.5-3.0 B.T.I. Biotechnology Institute, Sl. DZE Class II 2009-10-06
K091878 OSSEOLINK DENTAL IMPLANT SYSTEM Global Implant Solutions, LLC DZE Class II 2009-10-06
K090716 BEGO SEMADOS S-LINE Bego Implant Systems GmbH & Co. KG DZE Class II 2009-10-06
K091907 NOBELPROCERA IMPLANT BRIDGE ZIRCONIA Nobel Biocare AB NHA Class II 2009-10-06
K091217 DBX DEMINERALIZED BONE MATRIX PUTTY Musculoskeletal Transplant Foundation NUN Class II 2009-10-02

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