Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2007-12-06
Clearances · page 46 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K072649 | SPI SYSTEM DENTAL IMPLANTS | Thommen Medical AG | DZE | Class II | 2007-12-06 |
| K073141 | SPI ART ABUTMENT | Thommen Medical AG | NHA | Class II | 2007-12-05 |
| K072577 | BISICO IMPRESSION SILICONES & ALGINATES | Bisico GmbH & CO KG | ELW | Class II | 2007-12-05 |
| K072622 | STANDOUT 2 | Kerr Corp. | ELW | Class II | 2007-12-04 |
| K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | Tokuyama Dental Corporation | EBF | Class II | 2007-12-04 |
| K072830 | RM BOND, MODEL J032 | Pentron Clinical Technologies | DYH | Class II | 2007-12-04 |
| K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, Inc. | NHA | Class II | 2007-12-03 |
| K072463 | SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM | Satyrne Medical | JEY | Class II | 2007-11-29 |
| K062931 | IMPLUS IMPLANT SYSTEM | Leader Italia S.R.L. | DZE | Class II | 2007-11-28 |
| K073108 | ZENO ZR DISC | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | 2007-11-21 |
| K072807 | I LIGHT | Dent'N CO | EBZ | Class II | 2007-11-21 |
| K072480 | GENERATION 8 SE ADHESIVE | Pentron Clinical Technologies | KLE | Class II | 2007-11-21 |
| K070228 | IMPLANTIUM PROSTHETICS | Dentium Co., Ltd. | NHA | Class II | 2007-11-20 |
| K072309 | MICROLUX/BLU | Addent, Inc. | EAZ | Class I | 2007-11-19 |
| K072030 | IMPLANT CENTER | Satelec - Acteon Group | DZI | Class II | 2007-11-19 |
| K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS | Atlantis Components, Inc. | NHA | Class II | 2007-11-16 |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | DZE | Class II | 2007-11-16 |
| K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | NHA | Class II | 2007-11-16 |
| K072604 | DUO TEMP | Coltene/Whaledent AG | EMA | Class II | 2007-11-16 |
| K072643 | CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US | Olympus Corporation | KZN | Class II | 2007-11-16 |
| K072933 | SPI CONTACT PLATFORM O 4.0 MM | Thommen Medical AG | DZE | Class II | 2007-11-15 |
| K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES | Sable Industries, Inc. | EFB | Class I | 2007-11-14 |
| K072479 | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD | Rapid Injection Systems Corp. | EBI | Class II | 2007-11-09 |
| K070935 | T.B.R. ZIRCONNECT | Sudimplant SA | DZE | Class II | 2007-11-09 |
| K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | NHA | Class II | 2007-11-09 |
| K070569 | SM INTERNAL./EXTERNAL IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2007-11-08 |
| K072245 | EMULATE ADVANCED | Cavex Holland BV | ELW | Class II | 2007-11-08 |
| K072896 | GS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2007-11-06 |
| K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | Lang Dental Mfg. Co., Inc. | EBI | Class II | 2007-11-05 |
| K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | KKO | Class II | 2007-11-05 |
| K072134 | SCHICK COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | MUH | Class II | 2007-11-02 |
| K072569 | METOXIT CAM-BLANKS | Metoxit AG | EIH | Class II | 2007-10-31 |
| K062542 | Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX | Z-Systems AG | DZE | Class II | 2007-10-29 |
| K071981 | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) | Bonart Co., Ltd. | ELC | Class II | 2007-10-26 |
| K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | Pentron Clinical Technologies | EBF | Class II | 2007-10-26 |
| K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | D B Orthodontics, Ltd. | OAT | Class II | 2007-10-26 |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | Keystone Dental, Inc. | DZE | Class II | 2007-10-23 |
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | Lifecore Biomedical, Inc. | DZE | Class II | 2007-10-23 |
| K071838 | NEOSS VARIOUS TITANIUM ABUTMENTS | Neoss, Ltd. | NHA | Class II | 2007-10-19 |
| K072402 | FLEX-STAR V | Cmp Industries, LLC | EBI | Class II | 2007-10-19 |
| K071851 | HDC STERILE SPIDER SCREW | Hdc S.R.L. | DZE | Class II | 2007-10-18 |
| K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | Collagen Matrix, Inc. | LYC | Class II | 2007-10-18 |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent, Inc. | EKZ | Class II | 2007-10-18 |
| K071888 | STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES | Straumann USA | NHA | Class II | 2007-10-15 |
| K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | Beijing North Pole Dental Handpiece Co., Ltd. | EFB | Class I | 2007-10-12 |
| K072679 | P.004 ABUTMENTS | Institut Straumann AG | NHA | Class II | 2007-10-12 |
| K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | Intra-Lock International | DZE | Class II | 2007-10-12 |
| K072713 | ION DENTAL RESIN SYSTEM | Dentsply International, Inc. | EBI | Class II | 2007-10-12 |
| K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. | EMA | Class II | 2007-10-10 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | DZE | Class II | 2007-10-10 |
| K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | NHA | Class II | 2007-10-05 |
| K071946 | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS | Atlantis Components, Inc. | NHA | Class II | 2007-10-05 |
| K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 | Zimmer Dental, Inc. | DZE | Class II | 2007-10-04 |
| K072342 | SULTAN TOOTH ROOT DESENSITIZER | Dentsply International, Inc. | LBH | Class II | 2007-10-03 |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Astra Tech AB | NHA | Class II | 2007-10-01 |
| K072069 | SPACER | Vericom Co., Ltd. | EBF | Class II | 2007-09-28 |
| K071919 | P.004 ABUTMENTS | Straumann USA (On Behalf of Institut Straumann Ag) | NHA | Class II | 2007-09-26 |
| K071357 | P.004 NC ANATOMIC ABUTMENTS | Institut Straumann AG | NHA | Class II | 2007-09-26 |
| K072497 | P.004 NC GOLD ABUTMENT FOR CROWNS | Institut Straumann AG | NHA | Class II | 2007-09-26 |
| K071970 | CLEAR IMAGE ALIGNER | Specialty Appliance Works, Inc. | NXC | Class II | 2007-09-25 |
| K063861 | GS SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2007-09-21 |
| K072244 | PLANMECA PROONE | Planmeca Oy | MUH | Class II | 2007-09-21 |
| K072338 | CERVITEC PLUS | Ivoclar Vivadent, Inc. | LBH | Class II | 2007-09-21 |
| K071615 | FIXAFLOSS | Sybron Dental Specialties, Inc. | EEF | Class I | 2007-09-21 |
| K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM | Zimmer Dental, Inc. | DZE | Class II | 2007-09-20 |
| K070478 | P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) | Straumann Manufacturing, Inc. | NHA | Class II | 2007-09-20 |
| K072181 | MINI LED AUTOFOCUS | Satelec | EBZ | Class II | 2007-09-19 |
| K071453 | SPI EASY 4.0 ABUTMENT | Thommen Medical AG | NHA | Class II | 2007-09-19 |
| K072357 | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM | Afp Imaging Corp. | MUH | Class II | 2007-09-18 |
| K071891 | STATIS DENTAL HANDPIECES | Scican , Ltd. | EFB | Class I | 2007-09-13 |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | Novocol, Inc. | EBF | Class II | 2007-09-13 |
| K072151 | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS | Straumann USA | NHA | Class II | 2007-09-11 |
| K071612 | MODUS TRILOCK 2.0/2.3/2.5 | Medartis AG | JEY | Class II | 2007-09-11 |
| K071965 | I-SURGE | Satelec | EFB | Class I | 2007-09-10 |
| K071429 | TI2200 TRANSILLUMINATION CABLE | Kerr Corporation | NTK | Class II | 2007-09-10 |
| K071688 | RELIANCE S.E.P. | Reliance Orthodontic Products, Inc. | KLE | Class II | 2007-09-07 |
| K071817 | OSTEOGRAF/N-300 | Dentsply Interntional | LYC | Class II | 2007-09-04 |
| K071858 | DENTAL MATRIX BAND | Fly Cast Technologies, Inc. | DZN | Class I | 2007-08-31 |
| K070549 | STRAUMANN P.004 RC GOLD ABUTMENT | Institut Straumann AG | NHA | Class II | 2007-08-31 |
| K071848 | IPS INLINE POM SYSTEM | Ivoclar Vivadent, Inc. | EIH | Class II | 2007-08-30 |
| K071555 | FORTAGEN ORAL MEMBRANE | Organogenesis, Inc. | NPL | Class II | 2007-08-30 |
| K071551 | QUICKBRIDGE TM CYLINDER AND CAP | Biomet 3i, Inc. | NHA | Class II | 2007-08-30 |
| K071485 | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 | Tpc Advanced Technology, Inc. | EIA | Class I | 2007-08-28 |
| K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS | Schutz-Dental GmbH | EIH | Class II | 2007-08-24 |
| K071424 | PMAX NEWTRON XS | Satelec - Acteon Group | ELC | Class II | 2007-08-24 |
| K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | Good Doctors Co., Ltd. | EBZ | Class II | 2007-08-23 |
| K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED | Merz Dental GmbH | EBG | Class II | 2007-08-21 |
| K071190 | ROOT ZX II | J. Morita USA, Inc. | EKX | Class I | 2007-08-17 |
| K072071 | STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS | Institut Straumann AG | NHA | Class II | 2007-08-15 |
| K071742 | BEAUTIFIL II | Shofu Dental Corp. | EBF | Class II | 2007-08-15 |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | The Argen Corporation | EIH | Class II | 2007-08-15 |
| K071500 | NANO-BOND II ADHESIVE SYSTEM | Pentron Clinical Technologies | KLE | Class II | 2007-08-10 |
| K071722 | DEEP BLUE | E.M.S Electro Medical Systems S.A | EBZ | Class II | 2007-08-10 |
| K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM | Altatec GmbH | NHA | Class II | 2007-08-10 |
| K071628 | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf | MQN | Class II | 2007-08-10 |
| K071674 | GC-ZIRCONIA | GC America, Inc. | EIH | Class II | 2007-08-09 |
| K072052 | OSTEOGRAF/D-300 | Dentsply International, Inc. | LYC | Class II | 2007-08-08 |
| K072056 | OSTEOGRAF/D-700 | Dentsply International, Inc. | LYC | Class II | 2007-08-06 |
| K072057 | OSTEOGRAF/LD-300 | Dentsply International, Inc. | LYC | Class II | 2007-08-06 |
| K072058 | MODIFICATION TO: OSTEOGRAF/N-700 | Dentsply Interntional | LYC | Class II | 2007-08-03 |
12,679 clearances in the Dental panel. Data: openFDA.