Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 32
- Latest Decision
- 2000-07-17
Clearances · page 67 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K001730 | GC FUJICEM | GC America, Inc. | EMA | Class II | 2000-07-17 |
| K001729 | FOCUS | Instrumentarium Corp. | EHD | Class II | 2000-07-13 |
| K001623 | SCULPTURE FLOW | Jeneric/Pentron, Inc. | EBF | Class II | 2000-07-11 |
| K000837 | PUMA DENTAL CHAIR AND UNIT | Castellini S.P.A. | EIA | Class I | 2000-07-11 |
| K001494 | MODIFICATION TO PROMPT L-POP | Espe Dental AG | KLE | Class II | 2000-07-07 |
| K001518 | GRADIA | GC America, Inc. | EBF | Class II | 2000-07-05 |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | EJS | Class II | 2000-07-05 |
| K001218 | CORRECT PLUS | Jeneric/Pentron, Inc. | ELW | Class II | 2000-07-05 |
| K001383 | SUPREMCAST V | American Dent-All, Inc. | EJH | Class II | 2000-07-05 |
| K001418 | ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S | Procera Sandvik, Inc. | EIH | Class II | 2000-07-05 |
| K000992 | MACROPOREDX DISTRACTOR SYSTEM | Macropore Biosurgery, Inc. | MQN | Class II | 2000-06-26 |
| K001481 | PALCERAM 49 | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-23 |
| K001640 | BIOSOFT RESIN | Biosoft International Corp. | EBI | Class II | 2000-06-23 |
| K001482 | AURENORM 75 KF | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-23 |
| K001439 | ORTHOCEPH OC100 D | Instrumentarium Corp. | MUH | Class II | 2000-06-22 |
| K001479 | PALCERAM 53 | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-21 |
| K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG | Sulzer Calcitek, Inc. | DZE | Class II | 2000-06-21 |
| K001480 | AURECAST 40 B | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-21 |
| K001269 | DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC | Dentalmatic Technologies, Inc. | EJH | Class II | 2000-06-21 |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | JEY | Class II | 2000-06-21 |
| K001360 | SIGNUM | J.F. Jelenko & Co., Inc. | EBF | Class II | 2000-06-20 |
| K001477 | AURELUX Y 84 PREMIUM | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-20 |
| K001478 | AURECAST SUPER INLAY | Aurex SA (Pty) , Ltd. | EJT | Class II | 2000-06-20 |
| K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | Davis Schottlander & Davis, Ltd. | EBI | Class II | 2000-06-16 |
| K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl. | EFT | Class I | 2000-06-16 |
| K990060 | MACH 7 | Kreativ, Inc. | KOJ | Class II | 2000-06-15 |
| K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 | Kay See Dental Mfg. Co. | EBG | Class II | 2000-06-13 |
| K000981 | CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX | C-Mix | EJH | Class II | 2000-06-13 |
| K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology | DZB | Class II | 2000-06-09 |
| K001114 | 3M QUIK TEMP TEMPORIZATION MATERIAL | 3M Company | EBG | Class II | 2000-06-09 |
| K001313 | AIRDENT II CS | Air Technologies, Inc. | KOJ | Class II | 2000-06-08 |
| K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | Bionx Implants, Inc. | JEY | Class II | 2000-06-08 |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF | Class II | 2000-05-30 |
| K000680 | VISION ESTHETIC PORCELAIN SYSTEM | Midatlantic Division of Dentrex, Inc. | EIH | Class II | 2000-05-25 |
| K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | Blue Sky Bio | LYC | Class II | 2000-05-25 |
| K000686 | KROM-ALGINATE AND ALGINATE PLUS | Cavex Holland BV | ELW | Class II | 2000-05-25 |
| K001041 | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD | Wieland Edelmetalle GmbH & Co. | EJT | Class II | 2000-05-23 |
| K000894 | C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO | Dental Ventures of America, Inc. | EBG | Class II | 2000-05-19 |
| K000597 | VITA RESPONSE | Vident | EIH | Class II | 2000-05-17 |
| K001260 | ALLROUND 55 LF | J.F. Jelenko & Co., Inc. | EJT | Class II | 2000-05-17 |
| K000530 | BELLEGLASS HP ENAMEL | Sybron Dental Specialties, Inc. | EBF | Class II | 2000-05-17 |
| K000799 | BELMONT UNIT, MODEL 2000 SERIES | Belmont Equipment Corp. | EIA | Class I | 2000-05-17 |
| K000078 | JETLITE 4000 | J. Morita USA, Inc. | EBZ | Class II | 2000-05-15 |
| K000510 | ART-M1, MODEL M1-1-ART-A1 | Bonart Co., Ltd. | ELC | Class II | 2000-05-15 |
| K992819 | WAND PLUS | Spintech, Inc. | EJI | Class II | 2000-05-11 |
| K000710 | MD 10, SEM, SM 12, CBM | NOUVAG AG | EFB | Class I | 2000-05-11 |
| K001196 | JEL BIOS 90 (CODE NAME RD-2401) | J.F. Jelenko & Co., Inc. | EJT | Class II | 2000-05-11 |
| K000189 | PQ1 | Ultradent Products, Inc. | KLE | Class II | 2000-05-11 |
| K000577 | YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA | The Yoshida Dental Mfg. Co., Ltd. | EIA | Class I | 2000-05-05 |
| K980672 | SIMPLEX AIRBRATOR (SAB-7) | Irt Management Corp. | KOJ | Class II | 2000-05-04 |
| K001248 | MULTI-PULSE 2000 | Imaging Sciences Intl., Inc. | EHD | Class II | 2000-05-04 |
| K000968 | 3181 DUO DELIVERY SYSTEM | A-Dec, Inc. | EIA | Class I | 2000-05-03 |
| K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | Walter Lorenz Surgical, Inc. | JEY | Class II | 2000-05-03 |
| K000967 | 4635 ASSISTANT'S INSTRUMENTATION | A-Dec, Inc. | EIA | Class I | 2000-05-03 |
| K000771 | DIMAX 2 | Planmeca Oy | EHD | Class II | 2000-05-03 |
| K000547 | ATR TECNIKA | Advanced Technology Research (A.T.R.) S.R.P. | EFB | Class I | 2000-05-03 |
| K000966 | 4631 DUO DELIVERY SYSTEM | A-Dec, Inc. | EIA | Class I | 2000-05-03 |
| K000140 | CLINI-DENT | The Precident Group | MAU | Class I | 2000-05-03 |
| K000672 | HELIODENT VARIO | Sirona Dental Systems GmbH | EHD | Class II | 2000-05-02 |
| K000954 | KERR GEL ETCHANT | Sybron Dental Specialties, Inc. | KLE | Class II | 2000-04-28 |
| K000428 | DIXI 2 | Planmeca Oy | EHD | Class II | 2000-04-28 |
| K001051 | RX EVEREST | Jeneric/Pentron, Inc. | EJT | Class II | 2000-04-28 |
| K000357 | EZ CONNECT RESIN | Kerr Dental Materials Center | EBF | Class II | 2000-04-28 |
| K001048 | LIGHT BOND (QUICK CURE) | Reliance Orthodontic Products, Inc. | DYH | Class II | 2000-04-27 |
| K994174 | FRIALIT-2 MH-2 ABUTMENT | Friadent GmbH | DZE | Class II | 2000-04-20 |
| K000163 | PM 2002 PROLINE/AEC | Planmeca Oy | EHD | Class II | 2000-04-18 |
| K000346 | EZ CONNECT | Kerr Dental Materials Center | EBG | Class II | 2000-04-14 |
| K993545 | TENAX WHITE POST | Coltene/Whaledent, Inc. | ELR | Class I | 2000-04-14 |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | EFW | Class I | 2000-04-14 |
| K994027 | ACTIVATOR PASTE | Harry J. Bosworth Co. | ELW | Class II | 2000-04-13 |
| K000112 | ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 | Dentsply Intl. | EIA | Class I | 2000-04-13 |
| K000426 | VIP- VARIABLE INTENSITY POLYMERIZER | Bisco, Inc. | EBZ | Class II | 2000-04-12 |
| K000878 | HONIGUM | Dmg USA, Inc. | ELW | Class II | 2000-04-11 |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Wallach Surgical Devices, Inc. | EKZ | Class II | 2000-04-11 |
| K000061 | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT | Minxray, Inc. | EHD | Class II | 2000-04-07 |
| K000941 | STERLTECH WATER PURIFIER | Sterltech, Inc. | EIA | Class I | 2000-04-06 |
| K000532 | JEL 15 | J.F. Jelenko & Co., Inc. | EJS | Class II | 2000-04-06 |
| K000213 | JELDENT BASIC LINE | J.F. Jelenko & Co. | ELM | Class II | 2000-04-06 |
| K000595 | DIMENSION PENTA L | Espe Dental AG | ELW | Class II | 2000-04-05 |
| K000629 | FLEXTIME | Heraeus Kulzer, Inc. | ELW | Class II | 2000-04-05 |
| K000951 | LUXAFORM | Dmg USA, Inc. | EBG | Class II | 2000-04-05 |
| K000049 | SUNI MAX | Satelec | EFB | Class I | 2000-04-04 |
| K000454 | DIMEX 2 | Planmeca Oy | MUH | Class II | 2000-03-31 |
| K992392 | RTLX | Infimed, Inc. | MUH | Class II | 2000-03-31 |
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | Espe Dental AG | ELW | Class II | 2000-03-30 |
| K000018 | BRANEMARK NOVUM | Nobel Biocare Uas, Inc. | DZE | Class II | 2000-03-30 |
| K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | Espe Dental AG | ELW | Class II | 2000-03-30 |
| K993129 | UCLA/UNIVERSAL ABUTMENT | Diamodent | DZE | Class II | 2000-03-28 |
| K000393 | NOVA CORDLESS CURING LIGHT | Nova/Da Vinci Systems, Inc. | EBZ | Class II | 2000-03-27 |
| K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | Sybron Dental Specialties, Inc. | EBF | Class II | 2000-03-24 |
| K994376 | FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA | Friadent GmbH | DZE | Class II | 2000-03-24 |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | EJR | Class I | 2000-03-24 |
| K000269 | BELLEGLASS HP OPACEOUS DENTIN | Sybron Dental Specialties, Inc. | EBF | Class II | 2000-03-23 |
| K994359 | BOND 1 C & B | Jeneric/Pentron, Inc. | KLE | Class II | 2000-03-21 |
| K994119 | SYNOCTA ANGLED ABUTMENTS | Straumann USA | DZE | Class II | 2000-03-17 |
| K994309 | SOLO ORTHO 2 | Sybron Dental Specialties, Inc. | DYH | Class II | 2000-03-17 |
| K000211 | BUILD-IT FR | Jeneric/Pentron, Inc. | EBF | Class II | 2000-03-17 |
| K994257 | LOCATOR IMPLANT ANCHOR | Zest Anchors, Inc. | DZE | Class II | 2000-03-17 |
| K000551 | IMAGE X-70 PLUS DENTAL X-RAY UNIT | Medical Device Consultants, Inc. | EHD | Class II | 2000-03-16 |
| K994368 | AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS | American Dental Products, Inc. | LFC | Class II | 2000-03-14 |
12,679 clearances in the Dental panel. Data: openFDA.