Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 45
- Latest Decision
- 1982-05-05
Clearances · page 120 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K820955 | BOND-ON | J. Aderer, Inc. | EJS | Class II | 1982-05-05 |
| K820537 | ULTRASONIC TOOTHBRUSH | Ultrasonic Plaque Control Laboratories | JEQ | Class I | 1982-04-27 |
| K820568 | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. | DZM | Class I | 1982-04-09 |
| K820685 | DENTURE ADJUSTMENT KIT | Camdent Laboratories | EBO | Class II | 1982-04-09 |
| K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. | EKM | Class I | 1982-04-09 |
| K820673 | SELF-CURING HARD DENTURE LINER | Coe Laboratories, Inc. | EBI | Class II | 1982-04-09 |
| K820245 | SAFE TDENT | Professional Dental Studios | EBO | Class II | 1982-04-09 |
| K820693 | MIDWEST LIGHT WAND | American Midwest | EBZ | Class II | 1982-04-09 |
| K820738 | LUSTRALLOY | Hoyt Laboratories | EJJ | Class II | 1982-04-09 |
| K820617 | DISPERSED PHASE ALLOY | Goldsmith & Revere, Inc. | EJJ | Class II | 1982-03-25 |
| K820215 | IMPROVED DYCAL | Dentsply Intl. | EJK | Class II | 1982-03-23 |
| K820489 | ULTRAFINE TRAY ADHESIVE | Buffalo Dental Mfg. Co., Inc. | ELW | Class II | 1982-03-19 |
| K820503 | SVENSK TK/2 | Peter Martin Associates, Inc. | JEQ | Class I | 1982-03-19 |
| K820284 | ROOT CANAL FILLING RESIN | Dentsply Intl. | KIF | Class II | 1982-03-19 |
| K820530 | T-IV ELITE ALLOY | Howmedica Corp. | EJS | Class II | 1982-03-19 |
| K820598 | HOT & COLD PULP TESTER #4001 | Analytic Technology | EAT | Class II | 1982-03-19 |
| K820456 | CROWN & BRIDGE RESIN FOR FABRICAT/DE | Rohm and Haas Co. | EBG | Class II | 1982-03-19 |
| K820389 | A DENTAL AMALGAM ALLOY (UNNAMED | Dentsply Intl. | EJJ | Class II | 1982-03-11 |
| K820163 | ENDOSSEOUS SCREW IMPLANT | General A. Nitznick, D.M.D. | DZE | Class II | 1982-03-11 |
| K820434 | CLASS OF CASTING ALLOYS TYPE III OR ALT | Howmedica Corp. | EJS | Class II | 1982-03-11 |
| K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS | National Patent Development Corp. | EBF | Class II | 1982-03-11 |
| K820433 | CLASS OF CASTING ALLOYS TYPE II OR ALTER | Howmedica Corp. | EJS | Class II | 1982-03-11 |
| K820432 | CLASS OF CASTING ALLOYS TYPE I OR ALTER | Howmedica Corp. | EJS | Class II | 1982-03-11 |
| K820328 | NICKEL-BASED DENTAL CASTING ALLOY | Dentsply Intl. | EJH | Class II | 1982-03-02 |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Cutter Laboratories, Inc. | EMA | Class II | 1982-03-02 |
| K820408 | CLASS OF CASTING ALLOYS TYPE IV OR ALT | Howmedica Corp. | EJS | Class II | 1982-03-02 |
| K820182 | SYBRON/KERR COMMAND | Sybron Corp. | EBF | Class II | 1982-03-02 |
| K820057 | LUXOR PORCELAIN | Jeneric Ind. | EIH | Class II | 1982-03-02 |
| K820318 | SPECIAL WHITE | J. Aderer, Inc. | EJT | Class II | 1982-03-02 |
| K820407 | CLASS OF PRECIOUS METAL CASTING ALLOYS | Howmedica Corp. | EJS | Class II | 1982-03-02 |
| K820013 | TITANIUM IMPLANT DEVICES | Bofors Nobelpharma, Inc. | DZE | Class II | 1982-03-01 |
| K813328 | MYERSON/KENSON GP POLYMER | Howmedica Corp. | EBD | Class II | 1982-02-24 |
| K820162 | TEC-SON II | California Technics, Inc. | ELC | Class II | 1982-02-24 |
| K820277 | GDC-1130 | Deringer-Ney, Inc. | EJT | Class II | 1982-02-24 |
| K813550 | HYBRID DENTAL PRODUCT | Dentsply Intl. | EBH | Class I | 1982-02-24 |
| K820023 | CONAGRAF TM DURAPATITE CONES | Sterling Drug, Inc. | LYC | Class II | 1982-02-24 |
| K820092 | SECURE-ON-TOUCH | Sci-Pharm, Inc. | DYH | Class II | 1982-02-24 |
| K820216 | ULTRA-WET | Buffalo Dental Mfg. Co., Inc. | ELW | Class II | 1982-02-24 |
| K820183 | SYBRON/KERR MIRROR 3 | Sybron Corp. | ELW | Class II | 1982-02-24 |
| K820181 | SYBRON/KERR CONTOUR | Sybron Corp. | EJJ | Class II | 1982-02-24 |
| K813380 | CAVIDENTIN | Bitan Int'L Marketing Co. | EMA | Class II | 1982-02-24 |
| K820104 | NUPRO* GEL TRAY | Johnson & Johnson Professionals, Inc. | KMT | Class I | 1982-02-23 |
| K820049 | CERILLIUM | Jelrus Technical Products Corp. | EJH | Class II | 1982-02-22 |
| K820061 | REVERSIBLE HYDROCOLLOID IMPRESSION MAT | Belport Co., Inc. | ELW | Class II | 1982-02-22 |
| K813190 | SOFT PLATE CUSHION | Leonard Russo Co. | EHS | Class II | 1982-02-05 |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Rinn Corp. | EGZ | Class I | 1982-01-29 |
| K813568 | ESTILUX POSTERIOR XR | Kulzer, Inc. | EBF | Class II | 1982-01-29 |
| K812804 | MODERN MATERIALS' INLAY CSTG. WAXES,A-C | Modern Materials | EGD | Class I | 1982-01-26 |
| K820006 | ZEON COMPOSITE RESIN SYSTEM | National Patent Development Corp. | EBF | Class II | 1982-01-22 |
| K820020 | SPRYCE, DENTURE CLEANSER | Richardson-Vicks, Inc. | EFT | Class I | 1982-01-22 |
| K813180 | SCOTCHBOND DENTAL ADHESIVE | 3M Company | KLE | Class II | 1982-01-12 |
| K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | Modern Materials | EGD | Class I | 1982-01-12 |
| K813418 | INZOMA NP | J. Aderer, Inc. | EJS | Class II | 1982-01-07 |
| K813417 | INZOMA P | J. Aderer, Inc. | EJT | Class II | 1982-01-07 |
| K813357 | CAULK OPAQUER | Dentsply Intl. | EBF | Class II | 1982-01-07 |
| K813348 | YOSHIDA RIDO-F, MODEL LM-01 | Kaycor Intl., Ltd. | EKX | Class I | 1982-01-07 |
| K813257 | ALVEOGRAF DURAPATITE(18-40 MESH) | Sterling Drug, Inc. | DZE | Class II | 1982-01-05 |
| K812858 | CHEMFIL | Dentsply Intl. | EMA | Class II | 1981-12-31 |
| K813200 | GDC-1136 CASTING ALLOY FOR PORCELAIN-FU | Ney | EJS | Class II | 1981-12-31 |
| K813248 | DENTAL FLOSS HOLDER | Sewon Industry | JES | Class I | 1981-12-31 |
| K813243 | CERAL-BASE METAL ALLOY | Sillard Products, Inc. | EJH | Class II | 1981-12-31 |
| K813227 | INTRAOSSEOUS DENTAL IMPLANT | Pacific Implant, Inc. | DZE | Class II | 1981-12-31 |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Fibra Sonics, Inc. | ELC | Class II | 1981-12-14 |
| K813015 | HELIOSEAL | Vivadent (Usa), Inc. | EBC | Class II | 1981-12-02 |
| K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL | Sci-Pharm, Inc. | EBF | Class II | 1981-11-24 |
| K813091 | FISSURE SEALER & BONDING AGENT | Sci-Pharm, Inc. | EBC | Class II | 1981-11-24 |
| K813106 | PORT-OP | Portec, Inc. | EIA | Class I | 1981-11-24 |
| K813070 | PERIOGRAF | Sterling Drug, Inc. | LYC | Class II | 1981-11-20 |
| K812363 | DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED | Jdm Commodities | EFW | Class I | 1981-11-20 |
| K812361 | PORTABLE TOOTHBRUSH KIT (NO SAMPLE) | Jdm Commodities | EFW | Class I | 1981-11-20 |
| K812364 | PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE | Jdm Commodities | EFW | Class I | 1981-11-20 |
| K812362 | DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST | Jdm Commodities | EFW | Class I | 1981-11-20 |
| K811101 | HYDROXYLAPATITE | Carbomedics, Inc. | LYC | Class II | 1981-11-20 |
| K812889 | ESTILUX POSTERIOR | Kulzer, Inc. | EBF | Class II | 1981-11-17 |
| K812827 | ORBIC* SPHERICAL ALLOY | Johnson & Johnson Professionals, Inc. | EJJ | Class II | 1981-11-16 |
| K812886 | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. | EKN | Class I | 1981-11-16 |
| K812321 | HYDROXI-FLEX IMPLANT | Impladent | DZE | Class II | 1981-10-29 |
| K812692 | FILES & REAMERS | Miltex Instrument Co. | EKS | Class I | 1981-10-23 |
| K812709 | STERILE DENTAL ROLL | Medspec Corp. | EFN | Class I | 1981-10-23 |
| K812532 | TEMP-FILL | Madrid Uso, Jr., D.D.S. | EMA | Class II | 1981-10-14 |
| K812680 | G-C IMPRESSION SYRINGE | G-C Intl. Corp. | EID | Class I | 1981-10-06 |
| K812406 | EXAFLEX IMPRESSION MATERIAL | G-C Intl. Corp. | ELW | Class II | 1981-10-06 |
| K812679 | G-C FIT-CHECKER IMPRESSION MATERIAL | G-C Intl. Corp. | ELW | Class II | 1981-10-06 |
| K812605 | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. | EAY | Class I | 1981-10-02 |
| K811867 | SR-ALGICAP | J. Aderer, Inc. | ELW | Class II | 1981-10-02 |
| K812549 | BEAUSEAL | Sci-Pharm, Inc. | EBC | Class II | 1981-09-25 |
| K812449 | ADAPTIC* C.F.S. | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1981-09-25 |
| K812546 | BEAUDENT | Sci-Pharm, Inc. | EBF | Class II | 1981-09-25 |
| K812548 | COBEAU | Sci-Pharm, Inc. | LBH | Class II | 1981-09-25 |
| K812550 | BEAUCAV | Sci-Pharm, Inc. | LBH | Class II | 1981-09-25 |
| K812545 | BEAUFILL | Sci-Pharm, Inc. | EBF | Class II | 1981-09-25 |
| K812568 | CAVITRON | G-C Intl. Corp. | EMA | Class II | 1981-09-25 |
| K812547 | BEAUBON | Sci-Pharm, Inc. | DYH | Class II | 1981-09-23 |
| K812551 | BEAUCOR | Sci-Pharm, Inc. | EBF | Class II | 1981-09-23 |
| K812454 | PAC-AID | Albert J. Anthony, Dmd | DZC | Class I | 1981-09-23 |
| K810913 | CAVITY VARNISH | Dentsply Intl. | LBH | Class II | 1981-09-21 |
| K812360 | PRECIOUS-METAL/PLASTIC ATTACH., AUXILL | Zl-Microdent-Attachments | EGG | Class I | 1981-09-21 |
| K812300 | LINGUAL BRACKET | American Ormco | EJF | Class I | 1981-09-21 |
| K812239 | UNITEK PALATAL BAR | Unitek Corp. | DYT | Class I | 1981-09-21 |
| K812120 | GINGI-PLAIN CORDS & BRAIDS | Belport Co., Inc. | JES | Class I | 1981-09-08 |
12,679 clearances in the Dental panel. Data: openFDA.