Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 42
- Latest Decision
- 1977-01-14
Clearances · page 127 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. | EFN | Class I | 1977-01-14 |
| K770009 | BIOBOND C&B POST SOLDER | Dentsply Intl. | EJT | Class II | 1977-01-10 |
| K761352 | DENTAL STAIN REMOVER | Concept, Inc. | EFW | Class I | 1977-01-03 |
| K761355 | SELFAST | Septodont, Inc. | EMA | Class II | 1977-01-03 |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. | EAY | Class I | 1977-01-03 |
| K761354 | CIMPAT (PINK AND WHITE) | Septodont, Inc. | EMA | Class II | 1977-01-03 |
| K760909 | THERMOMETER JARS AND CAPS | Plastics/Packaging | ELK | Class I | 1976-12-30 |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | Syntex Corp. | DYN | Class I | 1976-12-23 |
| K761275 | AIROTOS LF HANDPIECE | Dentsply Intl. | DZA | Class I | 1976-12-23 |
| K761247 | LT:200, LOVING TOUCH | Litton Dental Products | ELC | Class II | 1976-12-16 |
| K761246 | SONUS III | Litton Dental Products | ELC | Class II | 1976-12-16 |
| K761228 | LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM | Howmedica Corp. | DZL | Class II | 1976-12-15 |
| K761206 | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division | DZM | Class I | 1976-12-13 |
| K761203 | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. | EKN | Class I | 1976-12-13 |
| K760724 | PERITONEAL DIALYSIS SYSTEM | Physio-Control Corp. | EKX | Class I | 1976-11-23 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | DZA | Class I | 1976-11-19 |
| K761024 | RACESTYPTINE RINGS | Septodont, Inc. | EIG | Class I | 1976-11-19 |
| K760960 | SURGICAL WIRE DRIVER | American Safety Equipment Corp. | DZJ | Class II | 1976-11-19 |
| K760797 | SPIRAFLO DIALYZER, DISPOSABLE | Bentley Laboratories, Inc. | EJT | Class II | 1976-11-19 |
| K760929 | ACCUTORQ II | Ritter Co. | EFB | Class I | 1976-11-19 |
| K760958 | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | DZH | Class II | 1976-11-16 |
| K760987 | DIAMOND STONES | Adp Intl., Inc. | DZP | Class I | 1976-11-15 |
| K760983 | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. | EKN | Class I | 1976-11-15 |
| K760959 | SURGICAL CHISEL | American Safety Equipment Corp. | EMM | Class I | 1976-11-15 |
| K760957 | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | DZH | Class II | 1976-11-15 |
| K760980 | DENTAL ALLOY | Adp Intl., Inc. | EJJ | Class II | 1976-11-15 |
| K760982 | DENTAL VARNISH | Adp Intl., Inc. | LBH | Class II | 1976-11-15 |
| K760985 | HAND INSTRUMENTS | Adp Intl., Inc. | EKW | Class I | 1976-11-15 |
| K760981 | ALGINATE IMPRESSION MATERIAL | Adp Intl., Inc. | ELW | Class II | 1976-11-15 |
| K760979 | COMPOSITE MATERIAL | Adp Intl., Inc. | EBF | Class II | 1976-11-15 |
| K760978 | ZINC CEMENT | Adp Intl., Inc. | EMA | Class II | 1976-11-15 |
| K760984 | ORTHODONTIC INSTRUMENTS | Adp Intl., Inc. | JEX | Class I | 1976-11-15 |
| K760986 | CARBIDE DENTAL BURS | Adp Intl., Inc. | EJL | Class I | 1976-11-15 |
| K760805 | ULTRASONIC DENTAL PROPHYLAXIS DEVICE | Cavitron Corp. | ELC | Class II | 1976-10-21 |
| K760723 | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc. | EBL | Class I | 1976-10-21 |
| K760794 | FIBER OPTICS HIGH SPEED HANDPIECE | Midwest | EFB | Class I | 1976-10-20 |
| K760753 | CUTTER JEL-ALGINATE IMPRESSION MAT. | Cutter Laboratories, Inc. | ELW | Class II | 1976-10-20 |
| K760796 | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Midwest | EAY | Class I | 1976-10-20 |
| K760795 | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Midwest | EAY | Class I | 1976-10-20 |
| K760768 | FLEXIDENT DENTURE | Flexodent Corp. | EKO | Class II | 1976-10-15 |
| K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS | Cutter Laboratories, Inc. | EBH | Class I | 1976-10-15 |
| K760783 | BIOBOND-CROWN & BRIDGE CERAMIC BONDING | Dentsply Intl. | EJS | Class II | 1976-10-15 |
| K760752 | CUTTER FLEX-SILICONE IMPRESSION MAT. | Cutter Laboratories, Inc. | ELW | Class II | 1976-10-15 |
| K760755 | CUTTER SIL-SILICONE IMPRESSION MAT | Cutter Laboratories, Inc. | ELW | Class II | 1976-10-15 |
| K760008 | DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL | Kyocera International, Inc. | DZE | Class II | 1976-10-05 |
| K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | Ritter Co. | EAZ | Class I | 1976-10-05 |
| K760659 | CALCIPULPE | Septodont, Inc. | EJK | Class II | 1976-09-27 |
| K760657 | RACESTYPTINE CORD | Septodont, Inc. | EIG | Class I | 1976-09-27 |
| K760658 | DETARTRINE P | Septodont, Inc. | EJR | Class I | 1976-09-27 |
| K760656 | DETARTRINE Z | Mr. J. Garrick Eisenberg | EJR | Class I | 1976-09-27 |
| K760660 | HYDROL | Septodont, Inc. | LBH | Class II | 1976-09-27 |
| K760620 | SALIVA EJECTOR | Lorvic Corp. | DYN | Class I | 1976-09-21 |
| K760570 | ROBINSON MIDDLE EAR PROSTHESIS | Xomed, Inc. | EIB | Class I | 1976-09-21 |
| K760571 | FLOSS-A-LOT | E. T. Skinner | JES | Class I | 1976-09-15 |
| K760599 | DENTAL CHAIRS | Chayes Virginia, Inc. | KLC | Class I | 1976-09-15 |
| K760512 | TOOTHBRUSH | Asset Scientific & Pharmaceutical, Inc. | EFW | Class I | 1976-09-03 |
| K760445 | DENTAL PROPHYLAXIS UNIT ULTRASONIC | Branson Ultrasonics Corp. | ELC | Class II | 1976-08-26 |
| K760376 | CEMENT, RESIN DENTAL (SOLO-TACH) | L.D. Caulk Co. | DYH | Class II | 1976-08-23 |
| K760379 | DENTAL AMALGAM ALLOY (SPHERICAL II) | L.D. Caulk Co. | EJS | Class II | 1976-08-23 |
| K760400 | BONDING AGENT, VYTOL | L.D. Caulk Co. | KLE | Class II | 1976-08-23 |
| K760377 | FILLING, RESIN DENTAL (VYTOL) | L.D. Caulk Co. | EBF | Class II | 1976-08-23 |
| K760378 | CEMENT, RESIN DENTAL (AUTO-TACH) | L.D. Caulk Co. | DYH | Class II | 1976-08-23 |
| K760419 | ADHESION PROMOTOR | Lee Pharmaceuticals | EBD | Class II | 1976-08-23 |
| K760418 | 9075 | Lee Pharmaceuticals | EBC | Class II | 1976-08-23 |
| K760405 | SEALANT, NEW FILLED | L.D. Caulk Co. | EBC | Class II | 1976-08-23 |
| K760404 | BI-CENTRIC SYSTEM | Pelton & Crane Co. | KLC | Class I | 1976-08-23 |
| K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. | Lee Pharmaceuticals | EBF | Class II | 1976-08-23 |
| K760331 | TURBINE, AIR DRIVEN HANDPIECE (2000) | Litton Dental Products | EFB | Class I | 1976-08-11 |
| K760369 | POWDERLITE | The S. S. White Co. | EBF | Class II | 1976-08-11 |
| K760324 | BONDING AGENT, PRESTIGE | Lee Pharmaceuticals | KLE | Class II | 1976-08-03 |
| K760322 | CHAIR, ATTACHED INSTRUMENT DEL. SYS. | The S. S. White Co. | KLC | Class I | 1976-08-03 |
| K760323 | X-RAY UNIT, DENTAL DIAGNOSTIC | The S. S. White Co. | EAP | Class II | 1976-08-03 |
| K760238 | IMPRESSION MATERIAL, TRIFLEX SILICONE | Oratec Dental Products | ELW | Class II | 1976-07-26 |
| K760239 | CEMENT, ULTRA-BOND | Oratec Dental Products | EMA | Class II | 1976-07-26 |
| K760240 | IMPRESSION MATERIAL, TRIFLEX SILICONE | Oratec Dental Products | ELW | Class II | 1976-07-26 |
| K760225 | PUTTY, ACCOE | Coe Laboratories, Inc. | ELW | Class II | 1976-07-21 |
| K760231 | IMPRESSION MATERIAL, DENTAL SILICON RTV | Crown Delta Corp. | ELW | Class II | 1976-07-21 |
| K760226 | PASTE, ACCOE IMPRESSION | Coe Laboratories, Inc. | ELW | Class II | 1976-07-21 |
| K760122 | WILL-CERAM Y-2 | Williams Gold Refining Co., Inc. | EJT | Class II | 1976-07-16 |
12,679 clearances in the Dental panel. Data: openFDA.