Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2009-05-11
Clearances · page 42 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K090826 | MONOBOND PLUS | Ivoclar Vivadent, Inc. | KLE | Class II | 2009-05-11 |
| K090069 | PROCERA IMPLANT BRIDGE OVERDENTURE | Nobel Biocare AB | NHA | Class II | 2009-05-07 |
| K091267 | VONFLEX PUTTY | Vericom Co., Ltd. | ELW | Class II | 2009-05-06 |
| K083480 | INCLUSIVE ZIRCONIA ABUTMENT BLANKS | Inclusive Dental Solutions | NHA | Class II | 2009-05-05 |
| K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. | EIA | Class I | 2009-05-01 |
| K083633 | HS II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2009-05-01 |
| K090684 | AVANTE LEUCITE BLOCKS | Somerset Dental Products, Inc. | EIH | Class II | 2009-05-01 |
| K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | DZI | Class II | 2009-04-30 |
| K090701 | EMPRESS DIRECT | Ivoclar Vivadent, Inc. | EBF | Class II | 2009-04-29 |
| K090355 | OPAL SEAL | Ultradent Products, Inc. | DYH | Class II | 2009-04-29 |
| K083586 | I-FIX SYSTEM | Dentis Co., Ltd. | DZE | Class II | 2009-04-29 |
| K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | KKO | Class II | 2009-04-22 |
| K090992 | WELL-PASTE | Vericom Co., Ltd. | KIF | Class II | 2009-04-21 |
| K082325 | APEXUM ABLATOR | Apexum , Ltd. | EKX | Class I | 2009-04-21 |
| K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | Cowellmedi Co., Ltd. | DZE | Class II | 2009-04-20 |
| K090237 | HG II FIXTURE SYSTEM | Hiossen, Inc. | DZE | Class II | 2009-04-17 |
| K083871 | ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE | Astra Tech, Inc. | NHA | Class II | 2009-04-15 |
| K090519 | VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 | 3M Company | LBH | Class II | 2009-04-15 |
| K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | Dentsply International, Inc. | EBF | Class II | 2009-04-14 |
| K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, | Zimmer Dental, Inc. | NHA | Class II | 2009-04-07 |
| K090292 | PREMISE MODIFIED | Kerr Corp. | EBF | Class II | 2009-04-03 |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | Ventus Medical, Inc. | OHP | Class II | 2009-04-03 |
| K083569 | SURGYBONE | Silfradent S.R.L. | DZI | Class II | 2009-04-01 |
| K083432 | DRILL FREE MMF SCREW | KLS Martin L.P. | DZL | Class II | 2009-03-31 |
| K090106 | PRELUDE ONE | Danville Materials, Inc. | KLE | Class II | 2009-03-31 |
| K090644 | VITABLOCS, MODEL VX55-**** | Vita Zahnfabrik H.Rauter GmbH & Co. | EIH | Class II | 2009-03-31 |
| K090153 | SPI VARIOMULTI ANGLED ABUTMENT | Thommen Medical AG | NHA | Class II | 2009-03-27 |
| K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | Warantec Co., Ltd. | DZE | Class II | 2009-03-27 |
| K083869 | BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI | Btlock Srl | DZE | Class II | 2009-03-27 |
| K083739 | HYDRORISE AND HYDROSYSTEM | Zhermack S.P.A. | ELW | Class II | 2009-03-26 |
| K090083 | CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 | Unicare Biomedical, Inc. | LYC | Class II | 2009-03-23 |
| K083886 | SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 | Simpler One Stop | DZE | Class II | 2009-03-23 |
| K090454 | ALLURE MB CERAMIC BRACKETS | Dentsply Interntional | NJM | Class II | 2009-03-20 |
| K082594 | REMESENSE | Remedent NV | LBH | Class II | 2009-03-19 |
| K081554 | TOKUYAMA TISSUECARE | Tokuyama Dental Corporation | EBI | Class II | 2009-03-18 |
| K083858 | BOND BONE | Augma Biomaterials, Ltd. | LYC | Class II | 2009-03-17 |
| K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | Pascal Co., Inc. | LBH | Class II | 2009-03-16 |
| K090020 | BEL-CYPHER, MODEL Y977 | Takara-Belmont Co., Ltd. | MUH | Class II | 2009-03-13 |
| K083062 | ROOT CANAL XR | S & C Polymer GmbH | KIF | Class II | 2009-03-12 |
| K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM | Synthes (Usa) | JEY | Class II | 2009-03-12 |
| K090503 | ZQUIET MOUTHPIECE | Sleeping Well, LLC | LRK | Class II | 2009-03-10 |
| K083532 | ADX4000-L, DX3000-L | Dexcowin Co., Ltd. | MUH | Class II | 2009-03-10 |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | EJI | Class II | 2009-03-09 |
| K083543 | DENOVISMED DENTAL IMPLANT SYSTEMS | Denovis Medical, LLC | DZE | Class II | 2009-03-06 |
| K083192 | INCLUSIVE TITANIUM ABUTMENT BLANKS | Inclusive Dental Solutions | NHA | Class II | 2009-03-04 |
| K083005 | NANGEL | Teknimed, S.A. | LYC | Class II | 2009-03-04 |
| K083766 | PHOGLASS CEM | S & C Polymer GmbH | EMA | Class II | 2009-03-02 |
| K081851 | NEOSS ACCESS ABUTMENTS | Neoss, Ltd. | NHA | Class II | 2009-03-02 |
| K090369 | PRODRIVE LINE OF DENTAL HANDPIECES | Prodrive Systems, Inc. | EFB | Class I | 2009-02-27 |
| K083479 | BIOCRYL X | Great Lakes Orthodontics, Ltd. | EBI | Class II | 2009-02-27 |
| K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA | DZE | Class II | 2009-02-26 |
| K090260 | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS | Straumann Manufacturing, Inc. | DZE | Class II | 2009-02-26 |
| K083324 | LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM | Zest Anchors, Inc. | NHA | Class II | 2009-02-25 |
| K082286 | BIOACTYS | Graftys | LYC | Class II | 2009-02-24 |
| K083101 | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES | Sable Industries, Inc. | EFB | Class I | 2009-02-23 |
| K081419 | STRAUMANN DENTAL IMPLANT SYSTEM | Institut Straumann AG | DZE | Class II | 2009-02-20 |
| K083051 | FLOWTAIN & FLOWTAIN LV | Reliance Orthodontic Products, Inc. | DYH | Class II | 2009-02-20 |
| K083516 | PERIOGENIX | Oroscience, Inc. | EMA | Class II | 2009-02-20 |
| K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | Dentalez Group, Stardental Division | EBW | Class I | 2009-02-18 |
| K082791 | EMS AIR-FLOW MASTER | E.M.S Electro Medical Systems S.A | EFB | Class I | 2009-02-18 |
| K090135 | TRIMIRA IDENTAFI 3000 | Remicalm, LLC | NXV | Class II | 2009-02-17 |
| K083438 | BIFIX SE | Voco GmbH | EMA | Class II | 2009-02-13 |
| K083205 | NOBELACTIVE 8.5 MM & 18.0 MM | Nobel Biocare AB | DZE | Class II | 2009-02-13 |
| K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | Collagen Matrix, Inc. | LYC | Class II | 2009-02-12 |
| K073121 | NUBRACE INVISIBLE REMOVABLE ORTHODONTICS | Nubrace, Inc. | NXC | Class II | 2009-02-12 |
| K083561 | NEOSS PROACTIVE IMPLANT | Neoss, Ltd. | DZE | Class II | 2009-02-11 |
| K082137 | DLMS-ZIRBLOCKS | Dental Milling Laboratory Supplies (Dlms) | EIH | Class II | 2009-02-10 |
| K083326 | FLUOROCORE 2 | Dentsply International, Inc. | EBF | Class II | 2009-02-10 |
| K082556 | CLEARCORRECT | Clearcorrect, Inc. | NXC | Class II | 2009-02-06 |
| K083304 | TEMPOSIL 2 | Coltene/Whaledent AG | EMA | Class II | 2009-02-06 |
| K082875 | PORTABLE X-RAY SYSTEM, MODEL DXR -1 | Exaro Co., Ltd. | EHD | Class II | 2009-02-05 |
| K083544 | KAT IMPLANT SYSTEM | Kat Implants, LLC | NHA | Class II | 2009-02-02 |
| K083067 | MS SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2009-02-02 |
| K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | Altatec GmbH | DZE | Class II | 2009-01-30 |
| K083059 | AIR SONIC SCALER | Dpm USA Corp. | ELC | Class II | 2009-01-30 |
| K082973 | STER-MATE STERILE LAVAGE KIT | Dentsply Interntional | ELC | Class II | 2009-01-29 |
| K083297 | PITT-EASY DENTAL IMPLANT SYSTEM | Sybron Implant Solutions GmbH | DZE | Class II | 2009-01-28 |
| K083209 | ACRYLIC HERBST SPLINT APPLIANCE | Specialty Appliance Works, Inc. | LRK | Class II | 2009-01-27 |
| K083201 | ZMATCH BLOCK | Dentaim Co., Ltd. | EIH | Class II | 2009-01-26 |
| K083398 | CERCOM CEMENT | Denali R&D Corporation | EMA | Class II | 2009-01-26 |
| K082668 | BIO-SCREEN | Addent, Inc. | NXV | Class II | 2009-01-23 |
| K083647 | VALO, MODEL 5919 | Ultradent Products, Inc. | EBZ | Class II | 2009-01-23 |
| K083473 | CLEAR BRAVO | Denali R&D Corporation | EBC | Class II | 2009-01-22 |
| K081537 | CFS FLEXIBLE | Comfort and Flexible Systems | EBI | Class II | 2009-01-22 |
| K081811 | CARE3 PLUS | Nakanishi, Inc. | EFB | Class I | 2009-01-21 |
| K083652 | IBOND TOTAL ETCH | Heraeus Kulzer,GmbH | KLE | Class II | 2009-01-21 |
| K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | S & C Polymer GmbH | EMA | Class II | 2009-01-15 |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | A-Dec, Inc. | EFB | Class I | 2009-01-15 |
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | Implant Direct, LLC | NHA | Class II | 2009-01-14 |
| K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | Implant Direct, LLC | NHA | Class II | 2009-01-14 |
| K083036 | VOCO PROFLUORID L | Voco GmbH | LBH | Class II | 2009-01-12 |
| K082917 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | Medtronic Sofamor Danek | LYC | Class II | 2009-01-09 |
| K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | Kettenbach GmbH & Co. KG | ELW | Class II | 2009-01-09 |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | A-Dec, Inc. | EFB | Class I | 2009-01-07 |
| K082943 | IROOT BP, MODEL IRBP 4609 | Innovative Bioceramix, Inc. | KIF | Class II | 2009-01-06 |
| K082652 | BITTAR ZIRCONIA BLOCKS | Bittar Zirconia Block, LLC | EIH | Class II | 2008-12-30 |
| K083344 | HELIODENT PLUS | Sirona Dental Systems GmbH | EHD | Class II | 2008-12-23 |
| K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT | Zimmer Dental, Inc. | NHA | Class II | 2008-12-23 |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE | Class II | 2008-12-22 |
| K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS | Zimmer Dental, Inc. | DZE | Class II | 2008-12-19 |
12,679 clearances in the Dental panel. Data: openFDA.