Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 35
- Latest Decision
- 2007-08-03
Clearances · page 47 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT | Nobel Biocare AB | DZE | Class II | 2007-08-03 |
| K071245 | TALON AND REVERE | Talon Acrylics, Inc. | EBI | Class II | 2007-08-02 |
| K071590 | THERMA-CURE | Reliance Orthodontic Products, Inc. | DYH | Class II | 2007-07-31 |
| K071201 | ZEO CE LIGHT & ZEO QUICK PORCELAIN | Xpdent Corp | EIH | Class II | 2007-07-30 |
| K062436 | SIS SINUS IMPLANT STABILIZER | Mondeal Medical Systems GmbH | JEY | Class II | 2007-07-30 |
| K071251 | DEMI | Kerr Corporation | EBZ | Class II | 2007-07-26 |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. | OAT | Class II | 2007-07-26 |
| K071131 | UNO | 3M Espe AG Dental Products | KLE | Class II | 2007-07-25 |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | JEY | Class II | 2007-07-25 |
| K070784 | INION BIORESTORE | Inion OY | LYC | Class II | 2007-07-24 |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | Sybron Dental Specialties, Inc. | EBF | Class II | 2007-07-19 |
| K071260 | HERMES BOND 3 | 3M Espe AG Dental Products | KLE | Class II | 2007-07-17 |
| K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | ELL | Class II | 2007-07-11 |
| K071585 | P.004 HEALING ABUTMENTS AND CLOSURE SCREWS | Straumann USA | NHA | Class II | 2007-07-11 |
| K071452 | FL BOND II | Shofu Dental Corp. | KLE | Class II | 2007-07-09 |
| K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | A-Dec, Inc. | EFB | Class I | 2007-07-05 |
| K070811 | CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 | Dexco | MUH | Class II | 2007-07-05 |
| K063837 | SIGMA M | Instrumentarium Dental, Palodex Group OY | MUH | Class II | 2007-07-02 |
| K070699 | AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN | Pentron Ceramics, Inc. | EIH | Class II | 2007-06-29 |
| K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG | EJL | Class I | 2007-06-29 |
| K070744 | NARROW NECK TEMPORARY COPING | Institut Straumann AG | NHA | Class II | 2007-06-29 |
| K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS | Pulpdent Corporation | EBF | Class II | 2007-06-29 |
| K063768 | TITANIUM SCALLOPED ABUTMENT | Vident | NHA | Class II | 2007-06-27 |
| K070055 | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | LYC | Class II | 2007-06-25 |
| K070833 | ATLANTIS ABUTMENT FOR ASTRA IMPLANT | Atlantis Components, Inc. | NHA | Class II | 2007-06-22 |
| K071192 | BLUGOO HD | Lancer Orthodontics, Inc. | ELW | Class II | 2007-06-22 |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Hu-Friedy Mfg. Co., Inc. | ELC | Class II | 2007-06-21 |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE | Class II | 2007-06-21 |
| K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS | B.T.I. Biotechnology Institute, Sl. | NHA | Class II | 2007-06-21 |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | Kuraray Medical, Inc. | EBF | Class II | 2007-06-20 |
| K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | Dentalez, Inc. | EFB | Class I | 2007-06-15 |
| K061438 | ULTRAEZ DESENSITIZING GEL | Ultradent Products, Inc. | LBH | Class II | 2007-06-12 |
| K063106 | REVOIS IMPLANT SYSTEM | Curasan AG | NHA | Class II | 2007-06-11 |
| K070723 | FUTURABOND DC/SINGLE DOSE | Voco GmbH | KLE | Class II | 2007-06-07 |
| K071386 | AMARIS/AMARIS FLOW | Voco GmbH | EBF | Class II | 2007-06-05 |
| K071158 | AURALAY PIT & FISSURE SEALANT | Denali Corporation | EBC | Class II | 2007-06-05 |
| K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 | Vita | EBG | Class II | 2007-06-01 |
| K062636 | OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS | Implant Innovations, Inc. | DZE | Class II | 2007-06-01 |
| K070074 | LUBRINA, MODEL HIM-1 | J. Morita USA, Inc. | EFB | Class I | 2007-05-31 |
| K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 | Zimmer Dental, Inc. | DZE | Class II | 2007-05-30 |
| K070568 | DIO PROTEM IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2007-05-25 |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | Sybron Dental Specialties, Inc. | LRK | Class II | 2007-05-25 |
| K070070 | ASCENT DENTAL CLEANSER | CAO Group, Inc. | LBH | Class II | 2007-05-25 |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE | Class II | 2007-05-24 |
| K061323 | MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM | Bioinfera, Inc. | DZE | Class II | 2007-05-23 |
| K070956 | SEA2 SELF ETCH ADHESIVE | 3M Espe Dental Products | KLE | Class II | 2007-05-22 |
| K071267 | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN | Novamin Technology, Inc. | LBH | Class II | 2007-05-18 |
| K070562 | EZ PLUS IMPLANT SYSTEM | Megagen Co., Ltd. | NHA | Class II | 2007-05-18 |
| K070840 | GVC-100 | GC America, Inc. | EMA | Class II | 2007-05-15 |
| K070147 | INTERGRO ORAL | Biomet 3i | NUN | Class II | 2007-05-14 |
| K063634 | RTR SYRINGE | Septodont | LYC | Class II | 2007-05-11 |
| K070646 | ADHESE ONE | Ivoclar Vivadent, Inc. | KLE | Class II | 2007-05-11 |
| K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific | MQN | Class II | 2007-05-11 |
| K070677 | COLORISE | Zhermack S.P.A. | ELW | Class II | 2007-05-11 |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | ELM | Class II | 2007-05-11 |
| K070702 | FUSION RESIN CEMENT AND CORE KIT | Denali Corporation | EBF | Class II | 2007-05-10 |
| K063789 | WN SYNOCTA GOLD ABUTMENT | Straumann USA | NHA | Class II | 2007-05-10 |
| K070693 | AURAVUE PIT & FISSURE SEALANT | Denali Corporation | EBF | Class II | 2007-05-09 |
| K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | Ultradent Products, Inc. | KIF | Class II | 2007-05-08 |
| K070289 | ACQUASEAL BENZ | Acquamed Technologies, Inc. | LBH | Class II | 2007-05-04 |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | Ultradent Products, Inc. | DYW | Class II | 2007-05-03 |
| K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | Dentsply International, Inc. | ELC | Class II | 2007-05-02 |
| K062731 | ULTRASONIC SCALER, VARIOS 560 | Nakanishi, Inc. | ELC | Class II | 2007-05-01 |
| K070772 | PRESSX ZR | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | 2007-04-30 |
| K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | Implant Innovations, Inc. | DZE | Class II | 2007-04-30 |
| K070537 | ZIRBLOCK | Cdl Technologies, Inc. | EIH | Class II | 2007-04-30 |
| K063659 | EASY CURING PEN-STYLE LED CURING LIGHT | Dent Corp. Research & Development | EBZ | Class II | 2007-04-30 |
| K063779 | OSSEOSPEED 4.0S-6MM, MODEL 24619 | Astra Tech, Inc. | DZE | Class II | 2007-04-27 |
| K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | Progeny, Inc. | MUH | Class II | 2007-04-26 |
| K070413 | ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 | CAO Group, Inc. | KLE | Class II | 2007-04-26 |
| K070700 | FREEALGIN | Zhermack S.P.A. | ELW | Class II | 2007-04-25 |
| K062834 | OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 | Genoss Co., Ltd. | LYC | Class II | 2007-04-24 |
| K070535 | RETROPAN CCD-TWAIN-USB | Video Dental Concepts, Inc. | MUH | Class II | 2007-04-24 |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | Implant Innovations, Inc. | DZE | Class II | 2007-04-24 |
| K070022 | MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 | Mis Implants Technologies , Ltd. | DZE | Class II | 2007-04-20 |
| K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE | Leone S.P.A. | DZE | Class II | 2007-04-19 |
| K063468 | THE FUGO BLADE FOR DENTISTRY | Medisurg , Ltd. | EKZ | Class II | 2007-04-18 |
| K070290 | SPI VECTODRILL CERAMIC DRILLS | Thommen Medical AG | NDP | Class I | 2007-04-17 |
| K063842 | CYRTINA SYSTEM | Oratio B.V. | EIH | Class II | 2007-04-17 |
| K062130 | MEISINGER BENEX, MODEL BE001 | Hager& Meisinger GmbH | EMG | Class I | 2007-04-16 |
| K062102 | ODONCER | Teknimed, S.A. | LYC | Class II | 2007-04-16 |
| K070583 | NANO COMPOSITE | Cosmedent, Inc. | EBF | Class II | 2007-04-16 |
| K063790 | THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY | Class II | 2007-04-16 |
| K061277 | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING | Straumann USA | NHA | Class II | 2007-04-12 |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | EJR | Class I | 2007-04-12 |
| K070866 | ASC-12 PIEZOELECTRIC SCALER | Aseptico, Inc. | ELC | Class II | 2007-04-11 |
| K070523 | MODIFICATION TO: VELSCOPE | Led Dental, Inc. | NXV | Class II | 2007-04-05 |
| K070505 | KRYSTAL-X WIFI | Owandy | MUH | Class II | 2007-04-05 |
| K070182 | ZYGOMA IMPLANT (IMMEDIATE FUNCTION) | Nobel Biocare AB | DZE | Class II | 2007-04-04 |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE | Class II | 2007-04-02 |
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | NBL | Class II | 2007-03-30 |
| K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | DZL | Class II | 2007-03-30 |
| K070215 | TOKUYAMA BOND FORCE | Tokuyama Dental Corporation | KLE | Class II | 2007-03-30 |
| K070127 | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 | Kevin Vu, Dds | EMN | Class I | 2007-03-29 |
| K070697 | COE SOFT | GC America, Inc. | EBI | Class II | 2007-03-29 |
| K063874 | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE | Class II | 2007-03-29 |
| K070698 | COE COMFORT | GC America, Inc. | EBI | Class II | 2007-03-29 |
| K070304 | DIGORA PCT/DIGIPOD | Soredex Palodex Group OY | MUH | Class II | 2007-03-27 |
| K070045 | ZIRBLANK-PS AND ZIRBLANK-FS | Acucera, Inc. | EIH | Class II | 2007-03-26 |
| K063770 | ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | OAT | Class II | 2007-03-26 |
12,679 clearances in the Dental panel. Data: openFDA.