meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
36
Latest Decision
2014-05-12

Clearances · page 30 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133054 ENDOSEAL Maruchi KIF Class II 2014-05-12
K134055 ADX4000W Dexcowin Co., Ltd. MUH Class II 2014-05-09
K131557 RITTER IMPLANT SYSTEM Ritter Implants GmbH CO KG DZE Class II 2014-05-09
K130067 MRNA APPLIANCE Biomodeling Solutions, Lls LRK Class II 2014-05-08
K133731 NOBELACTIVE WIDE PLATFORM (WP) Nobel Biocare AB DZE Class II 2014-05-08
K141081 FILTEK BULK FILL POSTERIOR RESTROATIVE 3M Espe Dental Products EBF Class II 2014-05-08
K140070 LUXER SHADED ZIRCONIA Continental Dental Ceramics, Inc. EIH Class II 2014-05-07
K131468 DENRACLE DENTAL ABUTMENT Green Dentech Co, Ltd. NHA Class II 2014-05-06
K132178 MOSTDI DENTAL IMPLANT SYSTEM Mostdi Innovations Sdn Bhd DZE Class II 2014-04-30
K140146 COMFORTSOFT SOFT DENTURE LINER SYSTEM Whip Mix Corp. EBI Class II 2014-04-29
K132570 ELECTRIC HANDPIECE SYSTEM Ttbio Corp. EBW Class I 2014-04-29
K140125 NEW STETIC DENTAL AMALGAM ALLOY New Stetic OIV Class II 2014-04-29
K133271 OPTEO, VIDEOGRAPH HD Owandy MUH Class II 2014-04-28
K134045 ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM Zimmer Dental, Inc. NHA Class II 2014-04-25
K140247 MTA FILLAPEX Angelus Industria DE Productos Odontologicos SA KIF Class II 2014-04-25
K132933 THE MOSES ELITE APPLIANCE Allen J. Moses, Dds, Ltd. LRK Class II 2014-04-25
K133007 DX3000-L Dexcowin Co., Ltd. MUH Class II 2014-04-24
K132315 ERGONOMIC PRODUCTS WORKSTATION Ergonomic Products, Inc. EIA Class I 2014-04-18
K133421 STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW Straumann USA, LLC NHA Class II 2014-04-17
K133791 ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] Sterngold Dental, LLC NHA Class II 2014-04-16
K131734 ALL-BOND UNIVERSAL SC (NOT FINALIZED) Bisco, Inc. KLE Class II 2014-04-11
K132478 AIR-FLOW HANDY 3.0 E.M.S Electro Medical Systems S.A EFB Class I 2014-04-11
K131906 SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE Satelec - Acteon Group EBZ Class II 2014-04-11
K132825 RETROMTA-ORTHOMTA II Biomta KIF Class II 2014-04-10
K133285 STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker NEI Class II 2014-04-09
K134008 MD-FLEX HEAVY BODY Meta Biomed, Inc. ELW Class II 2014-04-09
K133182 HTFX-222 GC America, Inc. EBF Class II 2014-04-09
K132401 MEGA ISQ Osstell AB EKX Class I 2014-04-09
K133716 TRC-PASTE Km Corporation KIF Class II 2014-04-09
K133377 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE Nobel Biocare AB NHA Class II 2014-04-04
K133170 QUICK JET M Micron Corp. EFB Class I 2014-03-28
K133680 ENCORE SYSTEM Siesta Medical, Inc. ORY Class II 2014-03-26
K131760 WHIP MIX PREPPIES PLUS Whip-Mix Corp. EJR Class I 2014-03-26
K132144 KERATOR LK Consulting Group USA, Inc. DZE Class II 2014-03-21
K133211 ZIRTOUGH Kuraray Noritake Dental, Inc. EIH Class II 2014-03-20
K133231 DIGORA OPTIME Instrumentarium Dental, Palodex Group OY MUH Class II 2014-03-20
K132123 TRC-PEX, RADIC-SEALER Km Corporation KIF Class II 2014-03-20
K133613 INTRA-LOCK DENTAL IMPLANTS Intra-Lock International, Inc. DZE Class II 2014-03-20
K133398 STRYKER PEDIATRIC MANDIBLE DISTRACTOR Stryker MQN Class II 2014-03-20
K131258 SATURN DENTAL IMPLANT Cortex Dental Implants Industries , Ltd. DZE Class II 2014-03-17
K133608 TRINIA Bicon, LLC EBF Class II 2014-03-14
K132393 CERCOM II CEMENT Denali Corporation EMA Class II 2014-03-14
K133824 CERASMART GC America, Inc. EBF Class II 2014-03-14
K132322 NEWTRON P5 XS B.LED Satelec - Acteon Group ELC Class II 2014-03-11
K123276 MM-SEAL Micro-Mega Societe Anonyme KIF Class II 2014-03-10
K132267 NEWTRON P5, NEWTRON P5 B.LED Satelec - Acteon Group ELC Class II 2014-03-10
K133436 FLASH AR; FLASH AR QUICK 3M Deutschland GmbH ELW Class II 2014-03-07
K133527 SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT Osstem Germany GmbH ELW Class II 2014-03-07
K133400 FLASH BITE 3M Espe AG ELW Class II 2014-03-06
K133836 OPTIGLAZE COLOR GC America, Inc. EBD Class II 2014-03-06
K133339 ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED Zimmer Dental, Inc. DZE Class II 2014-03-04
K130618 SFI-ANCHOR Cendres & Metaux SA NHA Class II 2014-03-03
K132814 SFI-BAR IMPLANT ABUTMENTS Sterngold Dental, LLC NHA Class II 2014-02-25
K132599 SMILEBOND SYSTEM Millennium Company, LLC ELW Class II 2014-02-25
K133696 NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S NHA Class II 2014-02-25
K133510 NEODENT IMPLANT SYSTEM Jj Industria E Comercio DE Materiais Dentarios SA DZE Class II 2014-02-24
K123697 MATRICEL DENTAL BARRIER MEMBRANE Matricel GmbH NPL Class II 2014-02-24
K132480 AIR-FLOW HANDY 3.0 PERIO E.M.S Electro Medical Systems S.A EFB Class I 2014-02-24
K131066 AXIOM REG Anthogyr Sas DZE Class II 2014-02-21
K132219 STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, Straumann USA, LLC NHA Class II 2014-02-21
K132426 SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS Sylphar N.V. LBH Class II 2014-02-14
K132212 DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL Hager& Meisinger GmbH DZL Class II 2014-02-14
K130485 CONTROL SEAL Voco GmbH EBC Class II 2014-02-11
K133318 ADHESE UNIVERSAL Ivoclar Vivadent, AG KLE Class II 2014-02-11
K130991 NEXXZR(TM)T AND NEXXZR(TM)S Sagemax Bioceramics, Inc. EIH Class II 2014-02-10
K132070 VITA SUPRINITY(R) Vita Zahnfabrik H.Rauter GmbH & Co. EIH Class II 2014-01-31
K132356 SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST Scican GmbH EGS Class I 2014-01-31
K132746 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION Nobel Biocare USA, LLC NHA Class II 2014-01-30
K132725 JUVORA DENTQAL DISC Juvora EBI Class II 2014-01-23
K131644 ANKYLOS SYNCONE ABUTMENT 5(DEGREE) Dentsply International, Inc. NHA Class II 2014-01-22
K133907 VSP SYSTEM Medical Modeling, Inc. DZJ Class II 2014-01-22
K132609 EDS ULTRASONIC TIPS Essential Dental Systems, Inc. ELC Class II 2014-01-22
K132125 A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM A.B. Dental Devices , Ltd. DZE Class II 2014-01-21
K131151 ENDOCENTER Satelec - Acteon Group ELC Class II 2014-01-16
K132844 STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES Straumann USA, LLC NHA Class II 2014-01-15
K132984 SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S Ivoclar Vivadent, Inc. ELM Class II 2014-01-14
K130662 ET PROSTHETIC SYSTEM Osstem Implant Co., Ltd. NHA Class II 2014-01-10
K130235 SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY Hans Biomed Corp. NUN Class II 2014-01-10
K121235 LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker JEY Class II 2014-01-09
K130476 ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE Dental Morelli OAT Class II 2014-01-08
K133049 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS Biomet 3i DZE Class II 2014-01-08
K132923 FUSION SINGLE LINK Angelus Industria DE Productos Odontologicos SA KLE Class II 2014-01-03
K130572 INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM Implant Direct Sybron Manufacturing, LLC DZE Class II 2013-12-24
K131510 POLYDIMETHYLSILOXANE IMPRESSION MATERIAL Blackwell Device Consulting ELW Class II 2013-12-20
K132067 MULTI ANGLED ABUTMENT SYSTEM Hiossen, Inc. NHA Class II 2013-12-20
K133078 K-ETCHANT SYRINGE; NEEDLE TIP (E) Kuraray Noritake Dental, Inc. KLE Class II 2013-12-20
K132368 VAPOR CERAMIC BRACKET Orthodontic Design and Production, Inc. NJM Class II 2013-12-19
K131664 COPRA TEMP PMMA-DISK White Peaks Dental Systems GmbH & Co. KG EBG Class II 2013-12-18
K130797 LUCO HYBRID OSA APPLIANCE Luco Hybrid Osa Appliance, Inc. LRK Class II 2013-12-18
K132992 TI STAR IMPLANT SYSTEM T-Plus Implant Tech. Co., Ltd. DZE Class II 2013-12-18
K123861 AIDI DENTAL IMPLANT SYSTEM Aidi Biomedical, LLC DZE Class II 2013-12-12
K121873 AVINENT DENTAL IMPLANT SYSTEM Avinent Implant System S.L. DZE Class II 2013-12-11
K132519 STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT Stryker JEY Class II 2013-12-06
K132445 PIEZON 250 E.M.S Electro Medical Systems S.A ELC Class II 2013-12-06
K132242 INNO SLA SUBMERGED IMPLANT SYSTEM Cowellmedi Co., Ltd. DZE Class II 2013-12-06
K133213 STARCERAM H.C. Starck Ceramics GmbH EIH Class II 2013-12-05
K121177 BOND APATITE Augma Biomaterials, Ltd. LYC Class II 2013-12-05
K131682 UD IMPLANT SYSTEM Medimecca Co., Ltd. DZE Class II 2013-12-05
K132748 BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK Shofu Dental Corporation EBF Class II 2013-12-04
K131997 NEWTRON BOOSTER Satelec - Acteon Group ELC Class II 2013-11-26

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