Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 56
- Latest Decision
- 1980-05-28
Clearances · page 123 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K801208 | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. | ELE | Class II | 1980-05-28 |
| K801047 | PLY LESIVE | May-Pell Chemical Development Co. | LBH | Class II | 1980-05-20 |
| K800574 | VACUDENT LUMIX 65 | Vacudent Sales Corp. | EHP | Class I | 1980-05-20 |
| K800575 | VACUDENT LUMIX 70 | Vacudent Sales Corp. | EHP | Class I | 1980-05-20 |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | Henry Schein, Inc. | EGZ | Class I | 1980-05-20 |
| K801092 | PRISMA-FILL | Dentsply Intl. | EBF | Class II | 1980-05-20 |
| K801093 | PRISMA-BOND | Dentsply Intl. | KLE | Class II | 1980-05-20 |
| K800762 | PS3 TITANIUM SCREW DENTAL IMPLANT | Colmed, Ltd. | DZE | Class II | 1980-05-14 |
| K800829 | MYERSON R&KENSON R PORCELAIN ANT&POS.- | Myerson Tooth Corp. | ELL | Class II | 1980-05-08 |
| K800951 | CASTA-LLOY | U.S. Shizai Corp. | EJS | Class II | 1980-05-08 |
| K800919 | ORAVIEW BY WATER PIK | Teledyne, Inc. | EAX | Class I | 1980-05-08 |
| K800831 | PY-CO-PROX TM DENTAL BRUSH | Block Drug Company, Inc. | EFW | Class I | 1980-05-08 |
| K800994 | AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) | Howmedica Corp. | EJS | Class II | 1980-05-02 |
| K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Co. | EHY | Class I | 1980-04-29 |
| K800828 | MYERSON'S SPECIAL CROWN & BRIDGE RESIN | Myerson Tooth Corp. | EBG | Class II | 1980-04-29 |
| K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | EKN | Class I | 1980-04-29 |
| K800748 | SNAP-WAY HEADGEAR | Northwest Orthodontics, Inc. | DZB | Class II | 1980-04-10 |
| K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER | American Dental Research | EBC | Class II | 1980-04-10 |
| K800393 | POLY SULFIDE IMPRESSION PASTE W/CATALYST | American Dental Research | ELW | Class II | 1980-04-10 |
| K800392 | BRACKET BONDING SYSTEM METAL & PLASTIC | American Dental Research | DYH | Class II | 1980-04-10 |
| K800389 | ANTERIOR & POST. RESTORATIVE PASTE SYS. | American Dental Research | KLE | Class II | 1980-04-10 |
| K800735 | U-STYLE ADAPTER | American Midwest | EGS | Class I | 1980-04-10 |
| K800390 | ANT. & POST. RESTORATIVE POWDER LIQ. | American Dental Research | KLE | Class II | 1980-04-10 |
| K800458 | ORTHODONTICARTIDE | European Orthodontic Products | EBI | Class II | 1980-03-25 |
| K800548 | SUPERSIL | Harry J. Bosworth Co. | ELW | Class II | 1980-03-18 |
| K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW | Class II | 1980-03-18 |
| K800166 | DENTSPLY DENTURE CLEANER | Dentsply Intl. | JER | Class I | 1980-03-17 |
| K800276 | RITTER MODEL H COMPANION STOOL | Sybron Corp. | KLC | Class I | 1980-03-17 |
| K800395 | ARISTOSURG 250 | Halmon-Locren, Inc. | EIA | Class I | 1980-03-17 |
| K800438 | DENTAL CAVITY VARNISH, CONCENTRATED | Scientific Pharmaceuticals, Inc. | LBH | Class II | 1980-03-12 |
| K800400 | MAXUM DENTURE RESIN | Dentsply Intl. | EBI | Class II | 1980-03-12 |
| K800439 | ADR COMPOSITE RESTORATIVE | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1980-03-12 |
| K800448 | WATER PIK TRAVELER, MODEL 79 | Teledyne, Inc. | EFS | Class I | 1980-03-05 |
| K800133 | PANOREX II DENTAL X-RAY UNIT | Pennwalt Corp. | EHD | Class II | 1980-03-03 |
| K800063 | XR-710 | Pennwalt Corp. | EAP | Class II | 1980-03-03 |
| K800371 | WILL CERAM LITE-CAST B | Williams Gold Refining Co., Inc. | EJH | Class II | 1980-02-28 |
| K791160 | DENTALEEN | Denpac Corp. | EMA | Class II | 1980-02-21 |
| K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. | EKW | Class I | 1980-02-19 |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. | EKP | Class I | 1980-02-19 |
| K800293 | FILE, PULP CANAL | Ipco Corp. | EKS | Class I | 1980-02-19 |
| K800138 | TS-301 THREE-WAY PULP TESTER | Tamler-Stoneham Instruments | EAT | Class II | 1980-02-13 |
| K800210 | TONGUE HOLDER/SALIVA EJECTOR | Unitek Corp. | DYN | Class I | 1980-02-06 |
| K800154 | TOTE-BRUSH | Anja Marketing, Inc. | EFW | Class I | 1980-02-05 |
| K800163 | VIMEDIC SYSTEM TM | Medical Systems Group of Viskay, Inc. | EFA | Class I | 1980-02-05 |
| K800172 | SIROPORT | Siemens Corp. | KLC | Class I | 1980-02-05 |
| K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION | Espe Dental Products | ELW | Class II | 1980-02-05 |
| K792541 | MONOJECT PLASTIC DENTAL INJ. SYRINGE | Sherwood Medical Co. | EJI | Class II | 1980-02-01 |
| K800084 | RITTER MODEL J DENTAL CHAIR | Ritter Co. | KLC | Class I | 1980-01-29 |
| K792535 | PORTARAY | Siemens Corp. | EAP | Class II | 1980-01-28 |
| K800060 | PROVIT | Parker Laboratories, Inc. | EMA | Class II | 1980-01-23 |
| K792250 | CUTTER POINTS | Cutter Laboratories, Inc. | EHL | Class I | 1980-01-23 |
| K790555 | HEMO-WEDGE | Parker Laboratories, Inc. | DZN | Class I | 1980-01-17 |
| K792581 | GENERAL ELECTRIC PANELIPSE LD | General Electric Co. | EHD | Class II | 1980-01-16 |
| K792437 | RAFLEX 70 | Mdt Corp., Inc. | EAP | Class II | 1980-01-09 |
| K792663 | FLEXI-CUP IMPLANT | Impladent | DZE | Class II | 1980-01-09 |
| K792363 | SILAGUM | Parkell, Inc. | ELW | Class II | 1980-01-09 |
| K792307 | DENTIX DENTAL X-RAY UNIT | Precise Optics | EAP | Class II | 1980-01-09 |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | EIC | Class I | 1980-01-04 |
| K792245 | TEETH, DENTURE, PLASTIC | Dentsply Intl. | ELM | Class II | 1980-01-04 |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | EIC | Class I | 1980-01-04 |
| K792530 | PLAQUE-X DENTURE CLEANER | Nexell Corp. | JER | Class I | 1979-12-27 |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | EIC | Class I | 1979-12-19 |
| K792493 | GENTLE FLOSS | Paul E. Jaffe, D.M.D. | JES | Class I | 1979-12-13 |
| K792427 | PERMA-CRYL 20 | Coe Laboratories, Inc. | EBI | Class II | 1979-12-13 |
| K792391 | COTTON ROLL COMPRESSION CAPS | Parker Laboratories, Inc. | EFN | Class I | 1979-12-06 |
| K792445 | MW STRAIGHT ATTACHMENT | Midwest | EGS | Class I | 1979-12-06 |
| K792140 | COMPOSITE RESTORATIVE, PASTE/TYPE | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1979-11-30 |
| K792274 | TEMPO | Deringer-Ney, Inc. | EJS | Class II | 1979-11-30 |
| K792042 | DENTURE BASE RESIN | Dentsply Intl. | EBI | Class II | 1979-11-30 |
| K792303 | MW 8000-I | Midwest | EBF | Class II | 1979-11-27 |
| K792304 | MW-8000 | Midwest | EFB | Class I | 1979-11-27 |
| K791602 | SCI-PHARM POLIFIL ANTERIOR RESTORATIVE | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1979-11-27 |
| K792302 | LS-100 | Midwest | EFB | Class I | 1979-11-27 |
| K792003 | 1 STEP | Betta Dental, Inc. | DYH | Class II | 1979-11-27 |
| K792210 | GDC 802-DEVELOPMENT NAME | Deringer-Ney, Inc. | EJT | Class II | 1979-11-20 |
| K791771 | ORALUMINATOR III AUTO-LIGHT | Midwest | EAY | Class I | 1979-11-20 |
| K791973 | HOWMEDICA A-35 DENTAL ALLOY | Howmedica Corp. | EJS | Class II | 1979-11-20 |
| K792008 | HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY | Howmedica Corp. | EJS | Class II | 1979-11-20 |
| K791704 | MASTERSCALE II | Litton Dental Products | ELC | Class II | 1979-10-26 |
| K791576 | FORGET - DENTURE BONDING LIQUID | Norcliff Thayer, Inc. | KOL | Class I | 1979-10-26 |
| K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. | JER | Class I | 1979-10-26 |
| K791716 | PLAQUE-X DENTURE CLEANSER | Noxell | JER | Class I | 1979-10-23 |
| K791733 | LIGHT-PAK | Midwest | EAY | Class I | 1979-10-23 |
| K790823 | VISIO-DISPERS | Espe GmbH (Us) | EBF | Class II | 1979-10-22 |
| K790984 | KLIP-LITE | Innovators, Inc. | EAZ | Class I | 1979-10-22 |
| K791788 | MICRO-RING SYSTEM PRECISION ATTACH. | Howmedica Corp. | EGG | Class I | 1979-10-22 |
| K791088 | MONOJECT PULP-CAPPING MATERIAL | Sherwood Medical Co. | EJK | Class II | 1979-10-22 |
| K791326 | MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL | Sherwood Medical Co. | DZI | Class II | 1979-10-17 |
| K791223 | DEN-MAT DENTAL FLOSSER | Den-Mat Corp. | JES | Class I | 1979-10-09 |
| K791366 | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | Oratronics, Inc. | NRQ | Class II | 1979-10-09 |
| K791416 | PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT | Carbomedics, Inc. | LYC | Class II | 1979-10-09 |
| K791064 | DUO TWO LAYER DENTURE CLEANSER | Block Drug Company, Inc. | EFT | Class I | 1979-10-09 |
| K791304 | HOWMEDICA A-30 DENTAL ALLOY | Howmedica Corp. | EJT | Class II | 1979-10-04 |
| K791204 | MITER ENDOSTEAL BLADE IMPLANT | Depuy, Inc. | NRQ | Class II | 1979-09-28 |
| K791410 | AMALGAMATOR MODEL SDC-- | Sierra Laboratories, Inc. | EFD | Class I | 1979-09-19 |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Cavitron Corp. | ELC | Class II | 1979-09-19 |
| K791024 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | Litton Dental Products | ELC | Class II | 1979-09-17 |
| K791318 | MIRADAPT* DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1979-09-12 |
| K791319 | MIRADAPT* POLISHING INSTRUMENTS | Johnson & Johnson Professionals, Inc. | EJR | Class I | 1979-09-12 |
| K790895 | TONGUE SCRAPER | Peter G. Finamore, Sr. | LCN | Class I | 1979-09-04 |
12,679 clearances in the Dental panel. Data: openFDA.