Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2008-12-19
Clearances · page 43 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K081751 | ADIN DENTAL IMPLANTS SYSTEM | Adin Dental Implants System, Ltd. | DZE | Class II | 2008-12-19 |
| K082180 | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 | Angelus Industria DE Productos Odontologicos | EBI | Class II | 2008-12-17 |
| K083610 | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | 3M Company | EBF | Class II | 2008-12-17 |
| K081960 | INVISALIGN SYSTEM | Align Technology | NXC | Class II | 2008-12-17 |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | A-Dec, Inc. | EIA | Class I | 2008-12-17 |
| K080458 | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. | MQN | Class II | 2008-12-17 |
| K080542 | DISTRAX | John W. King | MQN | Class II | 2008-12-15 |
| K082603 | TRIMIRA OCS 3000 | Remicalm, LLC | NXV | Class II | 2008-12-12 |
| K082671 | HERCULITE ULTRA | Sybron Dental Specialties | EBF | Class II | 2008-12-11 |
| K082744 | BEAUTIBOND | Shofu Dental Corp. | KLE | Class II | 2008-12-11 |
| K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE | Major Prodotti Dentari S.P.A. | EBG | Class II | 2008-12-09 |
| K082591 | FLEXITIME BITE | Heraeus Kulzer, Inc., Dental Products Division | ELW | Class II | 2008-12-05 |
| K082972 | KODAK 9500 | Trophy | MUH | Class II | 2008-12-05 |
| K082749 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | DZE | Class II | 2008-12-04 |
| K082408 | LEDEX, MODEL: WL-070 | Dentmate Technology Co. , Ltd. | EBZ | Class II | 2008-12-03 |
| K081786 | ZIOCERA & CONVERTIBLE SYSTEM | Osstem Implant Co., Ltd. | NHA | Class II | 2008-12-02 |
| K082740 | GC AADVA ZR DISK | GC America, Inc. | EIH | Class II | 2008-11-26 |
| K082153 | MAJOR.REPAIR | Major Prodotti Dentari S.P.A. | EBI | Class II | 2008-11-25 |
| K082838 | ORLUS MINI SCREW | Ortholution Co., Ltd. | DZE | Class II | 2008-11-25 |
| K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 | SOADCO, S.L. | DZE | Class II | 2008-11-25 |
| K082753 | FUTURABOND M/FUTURABOND M SINGLE DOSE | Voco GmbH | KLE | Class II | 2008-11-24 |
| K080430 | STOMA BONE BLOCK SCREW | Storz AM Mark GmbH | DZL | Class II | 2008-11-21 |
| K081460 | TDS ABUTMENT | Pou YU Biotechnology Co., Ltd. | NHA | Class II | 2008-11-21 |
| K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | Den-Mat Holdings, LLC | EBZ | Class II | 2008-11-21 |
| K082299 | VERICORE IMPLANT ABUTMENTS | Whip-Mix Corp. | NHA | Class II | 2008-11-20 |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | Nobel Biocare USA, LLC | NHA | Class II | 2008-11-19 |
| K081981 | LANG DENTAL ACRYLIC PRIMER | Lang Dental Mfg. Co., Inc. | EBI | Class II | 2008-11-17 |
| K082434 | GDLS-200 | GC America, Inc. | EBF | Class II | 2008-11-14 |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | DZE | Class II | 2008-11-13 |
| K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | Bonart Co., Ltd. | EBZ | Class II | 2008-11-13 |
| K082463 | PROGENIX | Medtronic Sofamor Danek | NUN | Class II | 2008-11-10 |
| K082335 | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY | Class II | 2008-11-10 |
| K081128 | MOLAR IMPLANT | Nobel Biocare AB | DZE | Class II | 2008-11-07 |
| K081806 | IDI IMPLANT SYSTEM | Idi Biomedical, LLC | DZE | Class II | 2008-11-07 |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | Dentsply Interntional | NJM | Class II | 2008-11-07 |
| K083141 | SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM | Simpact, LLC | NHA | Class II | 2008-11-07 |
| K081088 | MYRAY SKYVIEW | Cefla S.C. | MUH | Class II | 2008-11-06 |
| K082171 | GRADIA CORE | GC America, Inc. | EBF | Class II | 2008-10-30 |
| K073307 | MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM | Bio-Technology USA, Inc. | JEY | Class II | 2008-10-29 |
| K082198 | DURASHIELD PLUS | Dentsply Intl., Inc. | LBH | Class II | 2008-10-29 |
| K081965 | MPOWRX SNORING SOLUTION | Mpowrx Health and Wellness Products, Inc. | LRK | Class II | 2008-10-27 |
| K081900 | TEMPORARY TOOTH REPLACEMENT | Ormco Corp. | DZE | Class II | 2008-10-24 |
| K082285 | EASY GLAZE | Voco GmbH | EBD | Class II | 2008-10-24 |
| K082532 | STRAUMANN GUIDED INSTRUMENTS | Straumann USA | DZI | Class II | 2008-10-21 |
| K082768 | G-BOND PLUS | GC America, Inc. | KLE | Class II | 2008-10-21 |
| K073645 | SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM | 659543 BC , Ltd. | DZE | Class II | 2008-10-21 |
| K082545 | STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS | Institut Straumann AG | NHA | Class II | 2008-10-17 |
| K080906 | CDB CLIP | Cdb Corporation | NJM | Class II | 2008-10-17 |
| K082158 | DENSEO FAIRY | Xpdent Corp | EIH | Class II | 2008-10-15 |
| K082213 | GS III FIXTURE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-10-14 |
| K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | Bicon, LLC | DZE | Class II | 2008-10-10 |
| K080559 | DIO SM IMPLANT SYSTEM | Dsi, Inc. | DZE | Class II | 2008-10-09 |
| K081884 | MAJOR.BASE 20 | Major Prodotti Dentari S.P.A. | EBI | Class II | 2008-10-08 |
| K081666 | ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS | Astra Tech, Inc. | NHA | Class II | 2008-10-07 |
| K082071 | ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT | Adpharma, Inc. | LBH | Class II | 2008-10-02 |
| K082058 | DYNAMATRIX | Cook Biotech, Inc. | NPL | Class II | 2008-10-02 |
| K082757 | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM | Bioplate, Inc. | JEY | Class II | 2008-10-01 |
| K082764 | STRAUMANN WN CARES TITANIUM ABUTMENT | Institut Straumann AG | NHA | Class II | 2008-10-01 |
| K081749 | AVANTE Z ZIRCONIA (AS)3 BLOCKS | Pentron Ceramics, Inc. | EIH | Class II | 2008-09-30 |
| K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX | Digimed Corporation | EHD | Class II | 2008-09-26 |
| K082523 | OSSTELL ISQ IMPLANT STABILITY METER | Osstell AB | EKX | Class I | 2008-09-26 |
| K081850 | BISQUE ZIRCONIA BLANKS, TYPE BYZ | Zircar Zirconia, Inc. | EIH | Class II | 2008-09-25 |
| K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT | Zimmer Dental, Inc. | NHA | Class II | 2008-09-25 |
| K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | Bisco, Inc. | EMA | Class II | 2008-09-25 |
| K081415 | DAMON 4CLEAR | Ormco Corp. | NJM | Class II | 2008-09-24 |
| K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | Lang Dental Mfg. Co., Inc. | EBI | Class II | 2008-09-22 |
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Imtec Corp. | DZE | Class II | 2008-09-19 |
| K081493 | INFILTRATION KIT | Dmg USA, Inc. | EBC | Class II | 2008-09-18 |
| K082257 | ZENO AI ECO DISC | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | 2008-09-18 |
| K081784 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek | LYC | Class II | 2008-09-17 |
| K081579 | INVENTUS IMPLANT SYSTEM | Inventus Co., Ltd. | DZE | Class II | 2008-09-17 |
| K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL | Pulpdent Corporation | EBG | Class II | 2008-09-17 |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | Lang Dental Mfg. Co., Inc. | EBG | Class II | 2008-09-17 |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Astra Tech AB | DZE | Class II | 2008-09-17 |
| K081226 | SIMPACT IMPLANT SYSTEM | Simpact, LLC | DZE | Class II | 2008-09-12 |
| K081694 | DENJECTOR | Dxm Co., Ltd. | EJI | Class II | 2008-09-12 |
| K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE | Handpiece Headquarters, Inc. - Hpr, Inc. | EFB | Class I | 2008-09-11 |
| K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | Kettenbach GmbH & Co. KG | ELW | Class II | 2008-09-08 |
| K081961 | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | NOF | Class II | 2008-09-05 |
| K071803 | ARDS DENTAL IMPLANTS | Ards, Ltd. | DZE | Class II | 2008-09-05 |
| K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | S & C Polymer GmbH | EMA | Class II | 2008-09-05 |
| K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | NEI | Class II | 2008-09-05 |
| K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | Meta Biomed Co., Ltd. | EMA | Class II | 2008-09-05 |
| K082383 | FORTOSS VITAL | Biocomposites, Ltd. | LYC | Class II | 2008-09-05 |
| K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | Sybron Dental Specialties, Inc. | ELC | Class II | 2008-09-04 |
| K080594 | MS SYSTEM (NARROW RIDGE) | Osstem Implant Co., Ltd. | DZE | Class II | 2008-09-03 |
| K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties, Inc. | EFB | Class I | 2008-09-03 |
| K081575 | HU/HS/HG PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | NHA | Class II | 2008-09-02 |
| K081925 | SNAPSHOT | Instrumentarium Dental, Palodex Group OY | MUH | Class II | 2008-09-02 |
| K073685 | OTA COLLAGEN BIOMATERIAL | Osseous Technologies of America | NPL | Class II | 2008-08-29 |
| K072213 | PERIMETRICS PERIOMETER | Perimetrics, Inc. | EKX | Class I | 2008-08-29 |
| K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | Pentron Clinical Technologies | EMA | Class II | 2008-08-29 |
| K081432 | HEALOS II BONE GRAFT SUBSTITUTE | Depuy Spine, Inc. | LYC | Class II | 2008-08-29 |
| K081699 | PLANMECA SOVEREIGN | Planmeca USA, Inc. | EIA | Class I | 2008-08-29 |
| K081550 | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO | Bonart Co., Ltd. | ELC | Class II | 2008-08-28 |
| K081903 | XIOS PLUS WALL-MODULE | Sirona Dental Systems GmbH | MUH | Class II | 2008-08-26 |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Bonart Co., Ltd. | DZI | Class II | 2008-08-25 |
| K081237 | CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT | Craftmaster Contour Equipment, Inc. | EIA | Class I | 2008-08-25 |
| K082294 | WESTAR SERIES DENTAL UNITS | Westar Medical Products, Inc. | EIA | Class I | 2008-08-22 |
| K081899 | ANYRAY PORTABLE X-RAY SYSTEM | E-Woo Technology Co., Ltd. | EHD | Class II | 2008-08-21 |
12,679 clearances in the Dental panel. Data: openFDA.