meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2013-06-20

Clearances · page 32 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K130486 FUTURABOND UNIVERSAL Voco GmbH KLE Class II 2013-06-20
K122551 PROVITEMP Itena Clinical EMA Class II 2013-06-14
K130787 QUANTUM DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. DZE Class II 2013-06-13
K122748 ENGLER 25K SERIES ULTRASONIC INSERTS Engler Engineering Corp. ELC Class II 2013-06-11
K130025 SONENDO ENDOTHERAPY SYSTEM Sonendo, Inc. ELC Class II 2013-06-11
K122521 PREVENT SEAL Itena Clinical EBC Class II 2013-06-11
K130446 FASTBRACES CERAMIC BRACKETS Orthodontic Design and Production, Inc. NJM Class II 2013-06-07
K120954 NOBELPROCERA PEEK ABUTMENTS Nobel Biocare AB NHA Class II 2013-06-05
K123653 SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) Bisco, Inc. LBH Class II 2013-06-03
K123823 INTERLIG Angelus Industria DE Productos Odontologicos EBF Class II 2013-05-31
K131404 FLASH AR PENTA / FLASH AR PENTA QUICK 3M Deutschland GmbH ELW Class II 2013-05-30
K123491 BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT Biodenta Swiss AG NHA Class II 2013-05-30
K130869 TAKE 1 ADVANCE Sybron Dental Specialties ELW Class II 2013-05-30
K123855 WATER-FILLED TEETHER Solid Toys Ind. , Ltd. KKO Class II 2013-05-24
K130184 ZENOLUX Wieland Dental + Technik GmbH & Co. KG EIH Class II 2013-05-24
K123925 MTM CLEAR ALIGNER IN-OFFICE Dentsply International, Inc. NXC Class II 2013-05-24
K130538 WINX SLEEP THERAPY SYSTEM Apnicure, Inc. OZR Class II 2013-05-22
K122519 DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM Dio Corporation DZE Class II 2013-05-21
K122804 ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM Intai Technology Corp. DZE Class II 2013-05-20
K122974 TRYOUT-VPS HOLDING PASTE Crown Delta Corp. EMA Class II 2013-05-17
K123022 NEODENT IMPLANT SYSTEM Jjgc Industria E Comercio DE Materiais Dentarios S DZE Class II 2013-05-17
K130647 XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML Heraeus Kulzer, LLC ELW Class II 2013-05-17
K130558 SOMNODENT HERBST; CLASSIC, FLEX Somnomed, Inc. LRK Class II 2013-05-17
K122124 PORTABLE X-RAY SYSTEM Osstem Implant Co., Ltd. EHD Class II 2013-05-16
K130924 BRUXZIR SHADED Prismatik Dentalcraft, Inc. EIH Class II 2013-05-16
K122614 VINTAGE MP PRESS OVER Shofu Dental Corporation EIH Class II 2013-05-16
K122559 BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS Biodenta Swiss AG NHA Class II 2013-05-03
K113539 REVOIS PRO IMPLANT STSYEM Riemser Arzneimittel AG DZE Class II 2013-05-03
K130216 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT Dentsply Implant NHA Class II 2013-05-01
K122664 ZUGA DENTAL IMPLANT SYSTEM Zuga Medical, Inc. DZE Class II 2013-04-30
K130222 STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC DZE Class II 2013-04-29
K122908 PRG BARRIER COAT Shofu Dental Corporation LBH Class II 2013-04-26
K123386 PERIOTYPE X-PERT Clinical House Europe GmbH DZE Class II 2013-04-26
K123755 MULTI ANGLED ABUTMENT Osstem Implant Co., Ltd. NHA Class II 2013-04-26
K122549 DENTO TEMP Itena Clinical EMA Class II 2013-04-26
K130643 ACCELEDENT AURA Orthoaccel Technologies, Inc. OYH Class II 2013-04-23
K121804 PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM Itena Clinical EMA Class II 2013-04-19
K122069 STORM MINI SCREW Lancer Orthodontics, Inc. OAT Class II 2013-04-11
K123784 STRAUMANN DENTAL IMPLANT SYSTEM Straumann USA, LLC DZE Class II 2013-04-10
K123786 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker JEY Class II 2013-04-09
K130371 CLEARFIL MAJESTY ES FLOW Kuraray Noritake Dental, Inc. EBF Class II 2013-04-09
K123664 INCORIS ZI Sirona Dental Systems GmbH EIH Class II 2013-04-08
K130237 PONTIC PAINT Reliance Orthodontic Products, Inc. NXC Class II 2013-04-05
K121281 SIMPLI SIMPLER IMPLANT SYSTEM Simpler Implant Solutions DZE Class II 2013-04-05
K122198 6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM Oco Biomedical DZE Class II 2013-04-05
K123410 HEALTHY SLEEP APPLIANCE Healthy Sleep Dental Laboratory LRK Class II 2013-04-05
K122501 AEI DR. TERAUCHI ULTRASONIC TIPS American Eagle Instruments, Inc. ELC Class II 2013-03-29
K124008 IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE Ivoclar Vivadent, Agin NHA Class II 2013-03-29
K130223 RMGI FILL Pulpdent Corporation EMA Class II 2013-03-29
K123512 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM Biodenta Swiss AG DZE Class II 2013-03-28
K123139 ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES Asi Medical, Inc. ELC Class II 2013-03-28
K123870 XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. DZE Class II 2013-03-27
K123118 INSIGNIA DIGICAST Ormco Corp. DYW Class II 2013-03-26
K130221 HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM Medimecca Co., Ltd. DZE Class II 2013-03-21
K123952 CEREC BLOCS C IN Sirona Dental Systems GmbH EIH Class II 2013-03-20
K123468 DEMI ULTRA Kerr Corporation EBZ Class II 2013-03-20
K122522 DENTOETCH QUICKBOND BOND ACTIVATOR Itena Clinical KLE Class II 2013-03-19
K123415 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED Biodenta Swiss AG DZE Class II 2013-03-19
K122918 RAYSCAN A-EXPERT Ray Co., Ltd. MUH Class II 2013-03-15
K123929 BEGOPAL+ Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO EJH Class II 2013-03-14
K123169 ORALID Forward Science, LLC NXV Class II 2013-03-13
K123416 INSIGNIA WITH ITERO Ormco Corp. DYW Class II 2013-03-13
K122602 NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS Nobel Biocare AB NHA Class II 2013-03-13
K120089 BIOGENESIS IMPLANT SYSTEM Biogenesis Co., Ltd. DZE Class II 2013-03-13
K121685 SOPROCARE Sopro NBL Class II 2013-03-12
K113042 REVOIS IMPLANT SYSTEM Riemser Arzneimittel AG DZE Class II 2013-03-08
K122806 IMAGE WORKS PANOURA Mic International MUH Class II 2013-03-08
K121285 ORAVAN OSA New Jersey Snoring Solutions LRK Class II 2013-03-08
K113717 ULTRASONIC SCALER Nakanishi, Inc. ELC Class II 2013-03-05
K121769 DENTOCORE / DENTOCORE BODY Itena Clinical EBF Class II 2013-03-05
K122955 DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM Wright Health Group , Ltd. ELM Class II 2013-03-01
K122016 REXTAR, REXTAR LCD Meta Biomed, Inc. EHD Class II 2013-03-01
K123761 VITA ENAMIC STAINS Innovation Meditech GmbH EBD Class II 2013-03-01
K123220 VERTEX THERMOSENS RIGID Vertex-Dental B.V. EBI Class II 2013-03-01
K121901 TI-MAX Z45 Nakanishi, Inc. EGS Class I 2013-02-28
K122647 SYNTHES PATIENT SPECIFIC PLATE Synthes, Inc. JEY Class II 2013-02-28
K123348 CLEAR ALIGNER ADHESIVE Reliance Orthodontic Products, Inc. DYH Class II 2013-02-28
K123615 IRIS - HIGH STRENGTH GLASS CERAMIC Dentsply Intl. EIH Class II 2013-02-22
K121406 INCLUSIVE TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. DZE Class II 2013-02-22
K121735 FIBER DISK AND BLOCK PERMANENT, TRINIA Bioloren S.R.L. EBF Class II 2013-02-21
K123824 VITRO FIL LC Dfl Industria E Comercio SA EMA Class II 2013-02-21
K123680 COPRANCOLOR White Peaks Dental Systems GmbH & Co. KG EIH Class II 2013-02-21
K123638 PEKKTON IVORY Cendres & Metaux SA EBG Class II 2013-02-21
K120861 FIN-S MICROIMPLANT Creekside Orthodontics OAT Class II 2013-02-21
K123613 SYNSPAR ADVANCED Ardent, Inc. EIH Class II 2013-02-20
K123595 NEXUS RMGI Kerr Corporation EMA Class II 2013-02-19
K122894 GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC Geistlich Pharma AG NPM Class II 2013-02-15
K123826 VITRO MOLAR Dfl Industria E Comercio SA EMA Class II 2013-02-14
K122925 NEW STETIC ARTIFICIAL TEETH New Stetic ELM Class II 2013-02-12
K122065 DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE Ormco Corp. NOF Class II 2013-02-08
K123545 INCORIS TZI Sirona Dental Systems GmbH EIH Class II 2013-02-01
K113530 ULTRASONIC SCALER Nakanishi, Inc. ELC Class II 2013-01-31
K123397 MULTILINK AUTOMIX Ivoclar Vivadent, AG EBF Class II 2013-01-31
K122300 T3 DENTAL IMPLANT Biomet 3i DZE Class II 2013-01-30
K113816 GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC America, Inc. NHA Class II 2013-01-30
K122890 INION CPS ORBITAL PLATES Inion OY JEY Class II 2013-01-29
K121800 POINT 500 HD POINT500C HD Pointnix Co., Ltd. MUH Class II 2013-01-24
K123304 SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO Ivoclar Vivadent, AG EBF Class II 2013-01-24
K121810 OSSEOSPEED ANGLED ABUTMENT EV Astra Tech AB NHA Class II 2013-01-23
K121098 HERO I DENTAL IMPLANT SYSTEM Kj Meditech Co., Ltd. DZE Class II 2013-01-17

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