Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2008-03-27
Clearances · page 45 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Dentsply Intl. | NHA | Class II | 2008-03-27 |
| K080228 | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH | Novamin Technology, Inc. | LBH | Class II | 2008-03-27 |
| K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | Salvin Dental Specialties, Inc. | DZL | Class II | 2008-03-26 |
| K080514 | PECD-01 AND PECD QUICK-01 | 3M Espe AG Dental Products | ELW | Class II | 2008-03-26 |
| K080203 | MTA ROOT CANAL SEALER | Dentsply Interntional | KIF | Class II | 2008-03-26 |
| K070184 | DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT | Ospol AB | DZE | Class II | 2008-03-24 |
| K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | EFB | Class I | 2008-03-20 |
| K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ | Class II | 2008-03-19 |
| K073698 | SECURE | Parkell, Inc. | EMA | Class II | 2008-03-19 |
| K080130 | OCCLUFAST CAD | Zhermack S.P.A. | ELW | Class II | 2008-03-14 |
| K080076 | RX DC X-RAY UNIT | Cefla S.C.R.L. | EHD | Class II | 2008-03-14 |
| K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX | Ace Surgical Supply Co., Inc. | DZE | Class II | 2008-03-13 |
| K073475 | SYSTEM PLUS | Continental Dental Laboratory | ELW | Class II | 2008-03-10 |
| K072425 | JNE IMPLANT SYSTEM | GC America, Inc. | DZE | Class II | 2008-03-10 |
| K073247 | US/SS/GS SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-03-07 |
| K073161 | REPLUS DENTAL IMPLANTS (HA) | Implant Direct, LLC | DZE | Class II | 2008-03-07 |
| K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT | Biomet 3i, Inc. | NHA | Class II | 2008-03-07 |
| K080286 | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS | Straumann USA | NHA | Class II | 2008-03-07 |
| K080387 | HU II / HS II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-03-07 |
| K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | Altatec GmbH | NHA | Class II | 2008-03-05 |
| K080035 | LED CURING LIGHT | Monitex Industrial Co., Ltd. | EBZ | Class II | 2008-03-03 |
| K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT | Atlantis Components, Inc. | NHA | Class II | 2008-02-29 |
| K073061 | THE PROXIVENT KIT | Coll Partners , Ltd. | LBH | Class II | 2008-02-29 |
| K073116 | EBI INTERNAL IMPLANT SYSTEM | Ebi, Inc. | DZE | Class II | 2008-02-28 |
| K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | NEA | Class II | 2008-02-28 |
| K080068 | BEAUTIFIL OPAQUER | Shofu Dental Corp. | EBF | Class II | 2008-02-28 |
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | EKM | Class I | 2008-02-27 |
| K072055 | LAVA FRAME, LAVA FRAME SHADE | 3M Espe AG Dental Products | NHA | Class II | 2008-02-26 |
| K071490 | LEONE ORTHODONTIC MINI IMPLANT | Leone S.P.A. | OAT | Class II | 2008-02-22 |
| K072129 | NOBELACTIVE ZIRCONIA ABUTMENT | Nobel Biocare AB | NHA | Class II | 2008-02-22 |
| K073314 | HEANY INDUSTRIES INC DENTAL XIRCONIA | Heany Industries, Inc. | EIH | Class II | 2008-02-21 |
| K073283 | GC GAM-100 | GC America, Inc. | EMA | Class II | 2008-02-20 |
| K072851 | POLYSTAR 79 DENTURE BASE RESIN | Cmp Industries, LLC | EBI | Class II | 2008-02-20 |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | DZE | Class II | 2008-02-15 |
| K072733 | 3M ESPE ADULT CROWN | 3M Company | EBF | Class II | 2008-02-15 |
| K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek | DYH | Class II | 2008-02-15 |
| K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | Dentsply International, Inc. | DZE | Class II | 2008-02-15 |
| K073588 | GC MODELS OPA-100 AND JC-50 | GC America, Inc. | DYH | Class II | 2008-02-15 |
| K072856 | SPI VARIOMULTI ABUTMENT | Thommen Medical AG | NHA | Class II | 2008-02-15 |
| K072447 | PENTABORN | Mediscitec, Inc. | DZE | Class II | 2008-02-15 |
| K073263 | PRO-V | Bisco, Inc. | EBG | Class II | 2008-02-14 |
| K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | Ace Surgical Supply Co., Inc. | DZE | Class II | 2008-02-14 |
| K072100 | GC AADVA ABUTMENT | GC America, Inc. | NHA | Class II | 2008-02-14 |
| K072107 | PERIOSCAN, MODEL: D 3496 | Sirona Dental Systems GmbH | ELC | Class II | 2008-02-14 |
| K073258 | ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT | Atlantis Components, Inc. | NHA | Class II | 2008-02-14 |
| K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | Dentsply International, Inc. | NHA | Class II | 2008-02-12 |
| K073435 | KODAK 9000, KODAK 9000 3D | Trophy | MUH | Class II | 2008-02-11 |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | DZE | Class II | 2008-02-08 |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | Ventus Medical, Inc. | OHP | Class II | 2008-02-08 |
| K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | LBH | Class II | 2008-02-08 |
| K073243 | LED PRO SEAL | Reliance Orthodontic Products, Inc. | EBD | Class II | 2008-02-08 |
| K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | Promident, LLC | EFB | Class I | 2008-02-07 |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | Procter & Gamble | EFW | Class I | 2008-02-06 |
| K071148 | ATLAS IMPLANT SYSTEM | Cowellmedi Co., Ltd. | DZE | Class II | 2008-02-06 |
| K073568 | PSL BIOZIR BLOCK | P.S.L. International, Inc. | EIH | Class II | 2008-02-06 |
| K080266 | WELL-PEX | Vericom Co., Ltd. | KIF | Class II | 2008-02-06 |
| K080265 | DENFIL ETCHANT-37 | Vericom Co., Ltd. | EBF | Class II | 2008-02-06 |
| K072959 | MS SYSTEM (DENTURE) | Osstem Implant Co., Ltd. | DZE | Class II | 2008-02-04 |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Scican , Ltd. | EFB | Class I | 2008-02-04 |
| K073554 | NEUN | Heraeus Kulzer,GmbH | EBF | Class II | 2008-02-04 |
| K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX | Biomet 3i, Inc. | DZE | Class II | 2008-01-31 |
| K073539 | PROVISA CEM | Cavex Holland BV | EMB | Class I | 2008-01-31 |
| K073004 | SOMNOMED BFLEX | Somnomed, Inc. | LRK | Class II | 2008-01-30 |
| K073209 | MAXCEM 2 | Kerr Corporation | MZW | Class II | 2008-01-29 |
| K072989 | AXIS SYSTEM | Dentsply Intl., Inc. | EFB | Class I | 2008-01-28 |
| K072754 | AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE | Axenic Dental, Inc. | EFB | Class I | 2008-01-25 |
| K073461 | ORTHO ANCHOR SCREWS | Mis Implants Technologies , Ltd. | OAT | Class II | 2008-01-25 |
| K071240 | IMPLASA-HOECHST GMBH IMPLANTS | Implasa-Hoechst GmbH | DZE | Class II | 2008-01-24 |
| K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional | EMA | Class II | 2008-01-23 |
| K073628 | SYNOCTA ABUTMENTS | Straumann USA | NHA | Class II | 2008-01-22 |
| K072978 | TENDER ORTHO BOND-ENA BOND-ENA ETCH | Micerium S.P.A. | DYH | Class II | 2008-01-17 |
| K073101 | AURAVENEER CEMENT | Denali Corporation | EMA | Class II | 2008-01-17 |
| K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | 3M Espe Dental Products | EMA | Class II | 2008-01-17 |
| K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | Odontit S.A. | DZE | Class II | 2008-01-14 |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | Nobel Biocare USA, LLC | DZE | Class II | 2008-01-11 |
| K072871 | MS SYSTEM (PROVISIONAL) | Osstem Implant Co., Ltd. | DZE | Class II | 2008-01-10 |
| K073296 | TEMPXN28 | 3M Espe AG Dental Products | EBG | Class II | 2008-01-09 |
| K073218 | MTA ADVANCED MATERIAL | Dentsply Interntional | KIF | Class II | 2008-01-07 |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | Prosurg, Inc. | JEY | Class II | 2007-12-28 |
| K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | Nobel Biocare AB | NHA | Class II | 2007-12-28 |
| K070857 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM | Nobel Biocare AB | DZE | Class II | 2007-12-28 |
| K073199 | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | NOF | Class II | 2007-12-21 |
| K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | Biomet 3i, Inc. | NHA | Class II | 2007-12-20 |
| K072980 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS | Nobel Biocare AB | DZE | Class II | 2007-12-20 |
| K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | Takara Belmont USA, Inc. | NRD | Class I | 2007-12-20 |
| K073518 | FLASHLITE REBEL* | Discus Dental, Inc. | EBZ | Class II | 2007-12-20 |
| K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | MQN | Class II | 2007-12-20 |
| K073117 | DENTIN DESENSITIZER AGENT | Dentsply Intl., Inc. | LBH | Class II | 2007-12-19 |
| K073350 | SCANORA 3D | Soredex Palodex Group OY | MUH | Class II | 2007-12-19 |
| K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | NJM | Class II | 2007-12-18 |
| K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | DZI | Class II | 2007-12-18 |
| K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | KLC | Class I | 2007-12-14 |
| K073043 | SET PP | Sdi , Ltd. | EMA | Class II | 2007-12-14 |
| K073284 | AIR-FLOW MASTER STANDARD | (Ems Sa) Electro Medical Systems | EFB | Class I | 2007-12-14 |
| K073040 | SMH FLEX S | Smh Biomaterial AG | EBI | Class II | 2007-12-13 |
| K073049 | SCREWPLUS DENTAL IMPLANTS (HA) | Implant Direct, LLC | DZE | Class II | 2007-12-13 |
| K073005 | ELITE GLASS | Zhermack S.P.A. | ELW | Class II | 2007-12-12 |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Imtec Corp. | DZE | Class II | 2007-12-12 |
| K073033 | LEGACY DENTAL IMPLANTS | Implant Direct, LLC | DZE | Class II | 2007-12-10 |
| K073353 | DO-ALL DENTAL HANDPIECE LUBRICANT | Prodrive Systems, Inc. | EFB | Class I | 2007-12-07 |
12,679 clearances in the Dental panel. Data: openFDA.