Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 34
- Latest Decision
- 2009-10-02
Clearances · page 41 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K091679 | LEFORTE SYSTEM BONE PLATE | Jeil Medical Corporation | JEY | Class II | 2009-10-02 |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Kensey Nash Corp. | NPL | Class II | 2009-10-02 |
| K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | Kettenbach GmbH & Co. KG | ELW | Class II | 2009-10-01 |
| K092539 | SEAMFREE | Apex Dental Materials, Inc. | EBF | Class II | 2009-10-01 |
| K092851 | MODEL GDCH-2000 | Global Dental Direct, Inc. | EIA | Class I | 2009-09-29 |
| K092020 | AADVA ZR COLORING LIQUID | GC America, Inc. | EIH | Class II | 2009-09-29 |
| K091920 | ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL | Astra Tech, Inc. | NHA | Class II | 2009-09-28 |
| K092715 | IROOT BP PLUS | Innovative Bioceramix, Inc. | KIF | Class II | 2009-09-28 |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | Thommen Medical AG | NHA | Class II | 2009-09-25 |
| K091904 | NOBELPROCERA ZI ABUTMENT | Nobel Biocare AB | NHA | Class II | 2009-09-25 |
| K091826 | ELEGANT | 3M Espe AG Dental Products | EIH | Class II | 2009-09-25 |
| K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | S & C Polymer GmbH | EMA | Class II | 2009-09-25 |
| K091964 | CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS | Procter & Gamble Co. | JES | Class I | 2009-09-24 |
| K091756 | NOBELPROCERA TI ABUTMENT | Nobel Biocare AB | NHA | Class II | 2009-09-22 |
| K091239 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | DZE | Class II | 2009-09-22 |
| K090718 | BELLUS SHADING KIT | 3M Espe AG Dental Products | EIH | Class II | 2009-09-21 |
| K092758 | X-CUBE | Saeshin Precision Co., Ltd. | EBW | Class I | 2009-09-21 |
| K091647 | INJECTAFIL | Apex Dental Materials, Inc. | EBF | Class II | 2009-09-21 |
| K091887 | LED CURING LIGHT, MODEL GT-1500 | Monitex Industrial Co., Ltd. | EBZ | Class II | 2009-09-18 |
| K092496 | COPRAN ZR/ORIGIN YZ | White Peaks Dental Systems GmbH & Co. KG | EIH | Class II | 2009-09-18 |
| K090216 | COLLAGEN DENTAL MEMBRANE IV | Collagen Matrix, Inc. | NPL | Class II | 2009-09-18 |
| K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX | Ace Surgical Supply Co., Inc. | DZE | Class II | 2009-09-16 |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, Inc. | ELW | Class II | 2009-09-16 |
| K090174 | TSI; ERI | Oco Biomedical | DZE | Class II | 2009-09-14 |
| K090911 | IST SNORING APPLIANCE | Dental Crafters | LQZ | Class II | 2009-09-11 |
| K091852 | BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 | Refractron Technologies Corp. | EIH | Class II | 2009-09-10 |
| K091632 | SPK SEALANT | 3M Company | EBC | Class II | 2009-09-03 |
| K091635 | VENUS DIAMOND FLOW | Heraeus Kulzer, LLC | EBF | Class II | 2009-09-03 |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | EFA | Class I | 2009-09-03 |
| K090377 | SINUS QUICK EB SYSTEM | Neobiotech Co., Ltd. | DZE | Class II | 2009-08-28 |
| K091705 | PRIMER PLUS | Bisco, Inc. | KLE | Class II | 2009-08-28 |
| K091706 | QUATTRO PORCELAIN SYSTEM | Dentsply International, Inc. | EIH | Class II | 2009-08-28 |
| K092537 | DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | MUH | Class II | 2009-08-27 |
| K092572 | CORE*IT DUAL | Spident Co., Ltd. | EBF | Class II | 2009-08-26 |
| K091144 | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES | Synthes (Usa) | JEY | Class II | 2009-08-25 |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters | EGS | Class I | 2009-08-20 |
| K091186 | KODAK 1500 INTRAORAL CAMERA | Carestream Health, Inc. | EIA | Class I | 2009-08-18 |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Air Techniques, Inc. | NBL | Class II | 2009-08-18 |
| K091533 | SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 | Garrison Dental Solutions | JEP | Class I | 2009-08-17 |
| K090727 | IMM DENTAL IRRIGATION TUBING SET | Innovative Medical Manufacturing Co. | EBW | Class I | 2009-08-13 |
| K081268 | SONIC AIR MM1500 + (MID), MODEL 50400014 | Micro-Mega Societe Anonyme | ELC | Class II | 2009-08-10 |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation | NJM | Class II | 2009-08-07 |
| K091494 | FLEXITIME FLOW | Heraeus Kulzer, Inc. | ELW | Class II | 2009-07-31 |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Pou YU Biotechnology Co., Ltd. | NHA | Class II | 2009-07-30 |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Pou YU Biotechnology Co., Ltd. | NHA | Class II | 2009-07-30 |
| K090850 | ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE | Apatech , Ltd. | LYC | Class II | 2009-07-30 |
| K091390 | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 | Hdc S.R.L. | OAT | Class II | 2009-07-30 |
| K091197 | PLANMECA PROSENSOR | Planmeca Oy | EHD | Class II | 2009-07-29 |
| K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | Cowellmedi Co., Ltd. | DZE | Class II | 2009-07-29 |
| K090154 | SPI DENTAL IMPLANT INICELL | Thommen Medical AG | DZE | Class II | 2009-07-27 |
| K090937 | E-STATIS 40 SYSTEM | Scican , Ltd. | EBW | Class I | 2009-07-24 |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | Dentsply Interntional | DYW | Class II | 2009-07-24 |
| K091894 | TEMPORARY C&B COMPOSITE | Voco GmbH | EBG | Class II | 2009-07-23 |
| K090817 | IONOLUX | Voco GmbH | EMA | Class II | 2009-07-23 |
| K083670 | UNIVERSAL, AESTHETICA, NATEA, NATURA | Euroteknika | DZE | Class II | 2009-07-23 |
| K091300 | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 | CAO Group, Inc. | KLE | Class II | 2009-07-23 |
| K091388 | GCUC-505 | GC America, Inc. | EBF | Class II | 2009-07-22 |
| K091252 | IMPLANT CENTER 2 | Satelec | DZI | Class II | 2009-07-22 |
| K091866 | PROGENY VANTAGE PANORAMIC X-RAY SYSTEM | Midmark | MUH | Class II | 2009-07-20 |
| K090941 | ADHESE ONE F | Ivoclar Vivadent, Inc. | KLE | Class II | 2009-07-17 |
| K090825 | SQ IS SYSTEM | Neobiotech Co., Ltd. | DZE | Class II | 2009-07-16 |
| K082849 | SILENT SLEEP | Craniofacial Pain Center of Idaho | LRK | Class II | 2009-07-16 |
| K090527 | SINUS QUICK IT SYSTEM | Neobiotech Co., Ltd. | DZE | Class II | 2009-07-14 |
| K090709 | CORTEX DENTAL IMPLANT SYSTEM | Cortex Dental Implants Industries , Ltd. | DZE | Class II | 2009-07-07 |
| K090434 | BECE PRESS | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | EIH | Class II | 2009-07-06 |
| K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | W&H Dentalwerk Buermoos GmbH | EFB | Class I | 2009-06-30 |
| K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. | ELZ | Class I | 2009-06-29 |
| K090976 | VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS | Whip-Mix Corp. | NHA | Class II | 2009-06-25 |
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | LQZ | Class II | 2009-06-24 |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | Pou YU Biotechnology Co., Ltd. | NHA | Class II | 2009-06-24 |
| K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | DZE | Class II | 2009-06-19 |
| K090347 | CAMLOG ABUTMENTS PS | Altatec GmbH | NHA | Class II | 2009-06-18 |
| K090476 | SYNTEC ORTHODONTIC MINI SCREW | Syntec Scientific Corp. | OAT | Class II | 2009-06-18 |
| K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | Philips Electronics UK Limited | KKO | Class II | 2009-06-18 |
| K091096 | NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 | Dental Solutions, Inc. | EIH | Class II | 2009-06-18 |
| K090843 | AMARIS GINGIVA OPAQUER | Voco GmbH | EBF | Class II | 2009-06-17 |
| K091106 | EQUIA | GC America, Inc. | EMA | Class II | 2009-06-17 |
| K090704 | MULTILINK IMPLANT | Ivoclar Vivadent, Inc. | EBF | Class II | 2009-06-17 |
| K091484 | NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT | Novabone Products, LLC | LYC | Class II | 2009-06-15 |
| K091020 | BLUEPHASE 20I | Ivoclar Vivadent, Inc. | EBZ | Class II | 2009-06-12 |
| K090747 | MI FLOW (GCUC-450) | GC America, Inc. | EBF | Class II | 2009-06-10 |
| K083669 | OBI | Euroteknika | DZE | Class II | 2009-06-08 |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | EBG | Class II | 2009-06-05 |
| K090397 | XPI ANGLED ABUTMENTS | Keystone Dental, Inc. | NHA | Class II | 2009-06-05 |
| K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH | NJM | Class II | 2009-06-05 |
| K091019 | SPEEDCEM | Ivoclar Vivadent, Inc. | EMA | Class II | 2009-06-04 |
| K083057 | I-MAX TOUCH | Owandy | MUH | Class II | 2009-06-02 |
| K090458 | DEXIS SENSOR | Dexis, LLC | MUH | Class II | 2009-05-28 |
| K082824 | FLUID FILLED TEETHER | Kids II | KKO | Class II | 2009-05-27 |
| K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp | NJM | Class II | 2009-05-27 |
| K090676 | MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES | Anthogyr | EFA | Class I | 2009-05-22 |
| K090452 | NEOSS IMPLANT SYSTEM 03.25 | Neoss, Ltd. | DZE | Class II | 2009-05-22 |
| K082111 | STRAUMANN MEMBRAGEL | Institut Straumann AG | NPK | Class II | 2009-05-22 |
| K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | Dentsply Intl., Inc. | DZE | Class II | 2009-05-22 |
| K091023 | METAMORPHOSIS | Kerr Corporation | EBF | Class II | 2009-05-21 |
| K090005 | BRANEMARK INTEGRATION BIOHELIX IMPLANTS | Branemark Integration AB | DZE | Class II | 2009-05-19 |
| K090793 | BONGROS HA | Bioalpha, Inc. | LYC | Class II | 2009-05-19 |
| K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | Villa Sistemi Medicali S.P.A. | EHD | Class II | 2009-05-18 |
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | Implant Direct, LLC | DZE | Class II | 2009-05-15 |
| K090391 | PULPDENT MICRO-HYBRID COMPOSITE | Pulpdent Corporation | EBF | Class II | 2009-05-11 |
12,679 clearances in the Dental panel. Data: openFDA.