Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 47
- Latest Decision
- 1981-09-08
Clearances · page 121 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K812169 | VISIO-FIL | Espe GmbH (Us) | EBF | Class II | 1981-09-08 |
| K811831 | MULTI-PURPOSE DENTAL SYRINGE | Centrix, Inc. | EJI | Class II | 1981-09-08 |
| K812277 | PRISMA-FIL COMPULES | Caulk Co., Div. Dentsply | EID | Class I | 1981-09-08 |
| K812115 | KETAC-CHEM | Espe-Premier Sales Co. | EMA | Class II | 1981-08-31 |
| K812117 | PERMAGUM ADHESIVE | Espe-Premier Sales Co. | KLE | Class II | 1981-08-31 |
| K812119 | NIMETIC-DISPERS | Espe-Premier Sales Co. | EBF | Class II | 1981-08-31 |
| K812118 | NIMETIC POLISHING PASTE | Espe-Premier Sales Co. | EJR | Class I | 1981-08-31 |
| K812116 | PERMAGUM | Espe-Premier Sales Co. | KLE | Class II | 1981-08-31 |
| K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT | Inventive Technology Int'L., Inc. | EKS | Class I | 1981-08-25 |
| K812092 | BETA POST | Paul B. Heller, D.M.D. | ELR | Class I | 1981-08-20 |
| K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM | Harry J. Bosworth Co. | EBF | Class II | 1981-08-20 |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | American Midwest | EBF | Class II | 1981-08-18 |
| K812101 | BAK-ON SP PORCELAIN ALLOY | Johnson & Johnson Professionals, Inc. | EJS | Class II | 1981-08-18 |
| K811668 | KULZER TRANSLUX VISIBLE LIGHT CURING | Kulzer, Inc. | EBZ | Class II | 1981-07-28 |
| K811582 | THE PLACER | Cavitron Corp. | EID | Class I | 1981-07-28 |
| K811563 | PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS | Williams Gold Refining Co., Inc. | EJS | Class II | 1981-07-28 |
| K811926 | SE WON(ALUMINUM) DENTAL FLOSS HOLDER | Sewon Industry | JES | Class I | 1981-07-28 |
| K811923 | R & S SERIES IMPLANTS | Suncoast Dental Corp. | DZE | Class II | 1981-07-24 |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | EIC | Class I | 1981-07-24 |
| K811258 | BASE METAL ALLOY | Dentsply Intl. | EJH | Class II | 1981-07-23 |
| K811667 | COLTENE PRESSURE SPOT INDICATOR | Coltene, Inc. | ELW | Class II | 1981-07-15 |
| K811665 | SR-ISOCETTE | J. Aderer, Inc. | ELK | Class I | 1981-07-15 |
| K811767 | COLTENE PRESIDENT IMPRESSION MATERIALS | Coltene, Inc. | ELW | Class II | 1981-07-15 |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | EIC | Class I | 1981-07-15 |
| K811666 | COLTENE COLTEX/COLTOFLAX | Coltene, Inc. | ELW | Class II | 1981-07-15 |
| K811555 | DENTAL FLOSS HOLDER | Sewon Industry | JES | Class I | 1981-07-01 |
| K811669 | DURAFILL MICROFILL RESTORATIVE MATERIAL | Kulzer, Inc. | EBF | Class II | 1981-07-01 |
| K811396 | SONUS V | California Technics, Inc. | ELC | Class II | 1981-06-26 |
| K811013 | SUMMAR NON-PRECIOUS, CERAMIC ALLOY | Shofu Dental Corp. | EJH | Class II | 1981-06-26 |
| K811521 | FUJI IONOMER TYPE I & II | G-C Intl. Corp. | EMA | Class II | 1981-06-26 |
| K811624 | VISIO-SEAL | Espe-Premier Sales Co. | EBC | Class II | 1981-06-26 |
| K811443 | ENHANCE DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1981-06-16 |
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. | ELS | Class II | 1981-06-16 |
| K811113 | RIESS-LUHR | Allomedic | DZA | Class I | 1981-06-16 |
| K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM | Coltene, Inc. | EBF | Class II | 1981-06-16 |
| K811407 | BA-93 | Deringer-Ney, Inc. | EJH | Class II | 1981-06-16 |
| K811237 | MAGNETIC RETENTION UNIT | Universiti Malaya | ECG | Class I | 1981-06-16 |
| K811145 | PNEUMATIC DENTAL SCALER | Innovate, Inc. | ELC | Class II | 1981-06-16 |
| K810764 | HY-BOND POLYCARBOXYLATE CEMENT | Shofu Dental Corp. | EMA | Class II | 1981-06-12 |
| K810765 | HY-BOND ZINC PHOSPHATE CEMENT | Shofu Dental Corp. | EMA | Class II | 1981-06-12 |
| K811103 | GE 900 | General Electric Co. | EHD | Class II | 1981-06-09 |
| K811175 | RECOH ROOT CANAL IRRIGATOR | Koei International, Inc. | EFS | Class I | 1981-05-27 |
| K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. | EJP | Class I | 1981-05-13 |
| K810977 | ENDODONTIC POST SYSTEMS | Preat Corp. | ECG | Class I | 1981-05-13 |
| K811154 | HOYT ECONO-TRAY | Hoyt Laboratories | KMT | Class I | 1981-05-13 |
| K811023 | ROOT CANAL KIT | Dentsply Intl. | ELC | Class II | 1981-05-05 |
| K810970 | ISOSIT TEETH | Bauer, Cheng & Associates, Inc. | ELM | Class II | 1981-05-05 |
| K811020 | REVERSIBLE HYDROCOLLOID IMPRESSION | Kottler Laboratories | ELW | Class II | 1981-05-05 |
| K810969 | ISOSIT C & B MATERIAL | Bauer, Cheng & Associates, Inc. | EBF | Class II | 1981-05-05 |
| K810972 | THE GNATHOMETER-M | Bauer, Cheng & Associates, Inc. | KZO | Class I | 1981-05-05 |
| K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. | EJP | Class I | 1981-05-05 |
| K810950 | VISIO-SEAL | Espe Dental Products | EBC | Class II | 1981-04-29 |
| K810839 | SPOTAR | Moyco Industries, Inc. | ELW | Class II | 1981-04-29 |
| K810869 | SILICONE ELASTOMER KIT | Rapid Injection Systems Corp. | EBI | Class II | 1981-04-29 |
| K810538 | PLASTICEPH | Morningstar Dental Co. | EAG | Class II | 1981-04-29 |
| K810912 | ALLOY COMPOSITE POLISH | Moyco Industries, Inc. | EJR | Class I | 1981-04-23 |
| K810907 | COLTENE ORALLY | Coltene, Inc. | EJJ | Class II | 1981-04-23 |
| K810822 | DENTAL PORCELAIN POWDER | Coors Biomedical Co. | EIH | Class II | 1981-04-21 |
| K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | Lee Pharmaceuticals | KIF | Class II | 1981-04-21 |
| K810864 | WATER PIK ORAL HYGIENE CENTER | Teledyne, Inc. | EFS | Class I | 1981-04-21 |
| K810715 | SECURE | Sci-Pharm, Inc. | DYH | Class II | 1981-04-21 |
| K810959 | SECURE | Sci-Pharm, Inc. | DYH | Class II | 1981-04-21 |
| K810666 | BRAUN TRAVEL | Gilette Medical Eval. Laboratory | JEQ | Class I | 1981-04-14 |
| K810687 | SR-IVOCAP | J. Aderer, Inc. | EBI | Class II | 1981-04-14 |
| K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | Dental-Material Gesellschaft | ELW | Class II | 1981-04-14 |
| K810805 | WATER PIK AUTOMATIC TOOTHBRUSH | Teledyne, Inc. | JEQ | Class I | 1981-04-14 |
| K810789 | GDC-1054 | Deringer-Ney, Inc. | EJT | Class II | 1981-04-14 |
| K810830 | HOYT COTTON ROLLS | Hoyt Laboratories | EFN | Class I | 1981-04-14 |
| K810686 | SR-IVOLEN | J. Aderer, Inc. | EBH | Class I | 1981-04-14 |
| K810523 | SR-IVOSEAL | J. Aderer, Inc. | ELW | Class II | 1981-04-14 |
| K810813 | DMG-POLISHABLE COMPOSITE | Dental-Material Gesellschaft | EBD | Class II | 1981-04-14 |
| K810037 | DENTAL CHEWING GUM (SUGARLESS) | Mcdennan Oral Products, Inc. | EJR | Class I | 1981-04-08 |
| K810595 | SILUX RESTORATIVE MATERIAL & ENAMEL BOND | 3M Company | EBF | Class II | 1981-03-24 |
| K810545 | PCA PERIOCARE PERIODONTAL DRESSING | Pulpdent Corp. of America | EMA | Class II | 1981-03-24 |
| K810611 | FULCAST/SUMMIT CASTING ALLOY | C.Vaupel Dental, Inc. | EJH | Class II | 1981-03-24 |
| K810517 | INSTA-BOND | Lee Pharmaceuticals | DYH | Class II | 1981-03-24 |
| K810594 | CRYSTALLOY-P | Shofu Dental Corp. | EJH | Class II | 1981-03-24 |
| K810382 | HYDROXYLAPATITE ALVEOLAR RIDGE MAIN | Carbomedics, Inc. | LYC | Class II | 1981-03-20 |
| K810521 | CO-SPAN 13.5 CASTING ALLOY | C.Vaupel Dental, Inc. | EJH | Class II | 1981-03-17 |
| K810380 | HOWMEDICA T-III G ALLOY | Howmedica Corp. | EJS | Class II | 1981-03-17 |
| K810479 | SUPPORT | Sci-Pharm, Inc. | EBF | Class II | 1981-03-17 |
| K810524 | SR-IVOTRAY SPECIAL | J. Aderer, Inc. | EHY | Class I | 1981-03-17 |
| K810407 | HYDROXYLATE ENAMEL BOND SYSTEM | Wallace A. Erickson & Co. | KLE | Class II | 1981-03-17 |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | EFH | Class I | 1981-03-17 |
| K810525 | SR-IVOTRAY UNIVERSAL | J. Aderer, Inc. | EHY | Class I | 1981-03-17 |
| K810096 | PORCELAIN POWDER FOR CLINICAL USE | Dentsply Intl. | EIH | Class II | 1981-03-04 |
| K810279 | DENTURE CLEANER | Mcdennan Oral Products, Inc. | EFT | Class I | 1981-02-23 |
| K810265 | VISIO-BAND | Espe-Premier Sales Co. | KLE | Class II | 1981-02-23 |
| K810266 | ETCHING GEL | Espe-Premier Sales Co. | EJK | Class II | 1981-02-23 |
| K810241 | CRYSTAL-BOND | American Ormco | DYH | Class II | 1981-02-12 |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | EBA | Class I | 1981-02-10 |
| K810210 | MAGIC-TOUCH | Sci-Pharm, Inc. | DYH | Class II | 1981-02-10 |
| K810149 | TONGUE CLEANER | Agp, Inc. | LCN | Class I | 1981-02-05 |
| K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER | Buffalo Dental Mfg. Co., Inc. | ELW | Class II | 1981-02-02 |
| K810094 | DENTURE RUBBER BASE MATERIAL | Bosworth Co. | EBI | Class II | 1981-02-02 |
| K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE | Buffalo Dental Mfg. Co., Inc. | ELW | Class II | 1981-01-28 |
| K810026 | DENTAL ENDODONTIC CEMENT | Witech Laboratory | EMA | Class II | 1981-01-28 |
| K810010 | ORTHODONTIC ELASTICS | Orec Corp. | ECI | Class I | 1981-01-28 |
| K803291 | ARTUS DRILL #2000 | Jedmed Instrument Co. | DZI | Class II | 1981-01-28 |
| K803290 | ARTUS DRILL #3000 | Jedmed Instrument Co. | DZI | Class II | 1981-01-28 |
12,679 clearances in the Dental panel. Data: openFDA.