Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 59
- Latest Decision
- 1978-08-21
Clearances · page 125 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K781242 | ALLOY, AMALGAM, DISP. CAPSULE | Lee Pharmaceuticals | EJJ | Class II | 1978-08-21 |
| K781281 | CEMENT, DENTAL/CAVITY LINER | Star Dental Mfg. Co. | EMA | Class II | 1978-08-21 |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals | DZS | Class I | 1978-08-21 |
| K781293 | RESTORATIVE SYSTEM PROFILE | The S. S. White Co. | EBF | Class II | 1978-08-18 |
| K781114 | ULTRAMATE 990 | Litton Dental Products | EIA | Class I | 1978-08-14 |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Sherwood Medical Industries | DZE | Class II | 1978-08-14 |
| K780997 | AMALGAM ALLOY | Syntex Corp. | EJJ | Class II | 1978-07-27 |
| K781045 | A-33 DENTAL ALLOY | Howmedica Corp. | EJT | Class II | 1978-07-27 |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Premier Dental Products Co. | EMN | Class I | 1978-06-30 |
| K781044 | ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM | Litton Dental Products | ELC | Class II | 1978-06-30 |
| K781018 | DX TOOTHBRUSH | Lever Brothers Company, Inc. | EFW | Class I | 1978-06-30 |
| K780814 | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. | DYT | Class I | 1978-06-30 |
| K780898 | INSTANT CURE-1 | Ultra-Light Corp. | EBZ | Class II | 1978-06-30 |
| K781034 | PREMIER INLAY PLACER | Premier Dental Products Co. | EKI | Class I | 1978-06-30 |
| K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | KMY | Class I | 1978-06-28 |
| K780967 | LEE-ALLOY | Lee Pharmaceuticals | EJJ | Class II | 1978-06-22 |
| K780811 | DENTAL ABRASIVE DEVICE | Cavitron Corp. | EHL | Class I | 1978-06-22 |
| K780808 | PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) | Dental Ventures of America, Inc. | ELC | Class II | 1978-06-22 |
| K780796 | ZYTRON | Premier Dental Products Co. | EBF | Class II | 1978-06-22 |
| K780965 | NEW RESTODENT | Lee Pharmaceuticals | EBF | Class II | 1978-06-22 |
| K780786 | DENTURE RELINE MATERIAL | Dentsply Intl. | EBI | Class II | 1978-06-14 |
| K780864 | DIAMOND STONES | Venture Technology, Inc. | DZP | Class I | 1978-06-14 |
| K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The | ECI | Class I | 1978-06-14 |
| K780832 | ESTILUX MICROFILL | Degussa Dental, Inc. | EBF | Class II | 1978-06-14 |
| K780833 | ESTIC MICROFILL | Degussa Dental, Inc. | EBF | Class II | 1978-06-14 |
| K780834 | PREVI DENT PROPHYLAXIS MINT NDC | Hoyt Laboratories | EJR | Class I | 1978-06-02 |
| K780778 | RTV SILICONE HAND KNEADABLE PUTTY | Crown Delta Corp. | ELW | Class II | 1978-05-31 |
| K780360 | MASSAGER, GUM/SSAGE POWERED GUM | Sunbeam Corp. | JEQ | Class I | 1978-05-26 |
| K780747 | SNAP-WAY | Northwest Orthodontics, Inc. | DZB | Class II | 1978-05-26 |
| K780722 | ADVANCED DENTURE SYSTEM | Advanced Marketing Research Co. | EKO | Class II | 1978-05-26 |
| K780752 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | EGS | Class I | 1978-05-26 |
| K780711 | MICRO-RING | Howmedica Corp. | EGG | Class I | 1978-05-26 |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) | KMT | Class I | 1978-05-17 |
| K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | EHZ | Class I | 1978-05-16 |
| K780746 | HYGIENIC RUBBER DAM FRAME | Hygienic Dental Mfg., Co., The | EJE | Class I | 1978-05-12 |
| K780743 | CLAMP FORCEPS | Hygienic Dental Mfg., Co., The | EJG | Class I | 1978-05-12 |
| K780744 | BRINKER TISSUE RETRACTORS | Hygienic Dental Mfg., Co., The | EEF | Class I | 1978-05-12 |
| K780745 | RUBBER DAM | Hygienic Dental Mfg., Co., The | EIE | Class I | 1978-05-12 |
| K780263 | SHIELD | Lorvic Corp. | EJK | Class II | 1978-05-03 |
| K780642 | LITECAST SOLDER | Williams Gold Refining Co., Inc. | EJH | Class II | 1978-05-03 |
| K780518 | ULTRANOVAR, DENTAL U.V. CURING LAMP | Demetron Research Corp. | EBZ | Class II | 1978-04-28 |
| K780678 | IMPRESSION TRAY | Rocky Mountain Orthodontics, Inc. | EHY | Class I | 1978-04-28 |
| K780646 | AIR-PWOERED COLDRILL | Medishield, Inc. | EKX | Class I | 1978-04-28 |
| K780483 | FIBER OPTIC HANDPIECE | Syntex Corp. | EFB | Class I | 1978-04-28 |
| K780641 | DENTAL ROTARY CARBIDE BURS 76EJL | Teledyne Densco | EJL | Class I | 1978-04-21 |
| K780560 | DENTAL AMALGAMATOR | L.D. Caulk Co. | EFD | Class I | 1978-04-21 |
| K780528 | PREMIER CARVERS, STYLE #21C & 21D | Premier Dental Products Co. | EKH | Class I | 1978-04-19 |
| K780469 | PANORAMIC X-RAY, DENTAL | Den-Tal-Ez Mfg Co., Inc. | EHD | Class II | 1978-04-10 |
| K780334 | ADHESIVE, BRACKET AND CONDITIONER RESIN | Rocky Mountain Orthodontics, Inc. | DYH | Class II | 1978-03-28 |
| K780400 | DEN-Z-ORB | Nice-Pak Products, Inc. | KHR | Class I | 1978-03-27 |
| K780239 | BRACKET, METAL REINFORCED PLASTIC | Ormco Corp. | DYW | Class II | 1978-03-15 |
| K780170 | ORTHODONTIC BRACKET PADS | Rocky Mountain Orthodontics, Inc. | EJF | Class I | 1978-03-15 |
| K780164 | RTV DENTAL SILICONE | Tydont, Inc. | ELW | Class II | 1978-03-15 |
| K780384 | IMPROVED DYCAL | L.D. Caulk Co. | EJK | Class II | 1978-03-15 |
| K780217 | ANTERIORS AND POSTERIORS, PLASTIC | Dentsply Intl. | ELM | Class II | 1978-03-15 |
| K780376 | MINIDENTOFLEX NEW POLISHING SYSTEM | Cavitron Corp. | EHL | Class I | 1978-03-14 |
| K780090 | DENTAL ALLOY | Krupp International, Inc. | EJH | Class II | 1978-03-14 |
| K780377 | PINIDENTOFLEX DENTAL POLISHER | Cavitron Corp. | EHL | Class I | 1978-03-14 |
| K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. | JER | Class I | 1978-03-09 |
| K780301 | CAULK TYLOK | L.D. Caulk Co. | EMA | Class II | 1978-02-28 |
| K780174 | ORABRITE | Norcliff Thayer, Inc. | JER | Class I | 1978-02-23 |
| K780213 | HANDPIECE, LIFT, ENDO | Kerr Corporation (Danbury) | EGS | Class I | 1978-02-17 |
| K780199 | PROPHY ANGLES, R&R | Ransom and Randolph | EGS | Class I | 1978-02-16 |
| K780198 | PROPHY CUPS, R&R | Ransom and Randolph | EHK | Class I | 1978-02-16 |
| K780205 | ORTHODONTIC BUCCAL TUBE | Rocky Mountain Orthodontics, Inc. | DZD | Class I | 1978-02-16 |
| K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Kerr Corporation (Danbury) | EHY | Class I | 1978-02-16 |
| K772244 | ILLUMINATED DENTAL HANDPIECE | Litton Dental Products | EFB | Class I | 1978-01-20 |
| K780038 | DENTAL HANDPIECE | Lares Manufacturing Co., Inc. | EFB | Class I | 1978-01-20 |
| K772351 | DENTAL LIGHT | Chemetron Dental Products | EAZ | Class I | 1978-01-17 |
| K780028 | ORTHODONTIC. PLASTIC BRACKET PRIMER | 3M Company | DYH | Class II | 1978-01-17 |
| K771974 | SOLVENEX I-0 | Den-Mat Corp. | KZP | Class II | 1978-01-12 |
| K771114 | NEUTROCIM | Septodont, Inc. | EMA | Class II | 1978-01-04 |
| K772304 | DENTAL IMPLANT, CARBON COATED METAL | General Atomic Co. | DZE | Class II | 1978-01-03 |
| K772316 | MATRIX STRIP, DEAD-SOFT | Den-Mat Corp. | DZN | Class I | 1978-01-03 |
| K772314 | WEDGES, RETAINING, MATRIX | Den-Mat Corp. | DZN | Class I | 1978-01-03 |
| K772279 | FOTOFILL DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1978-01-03 |
| K772278 | FOTOFILL ACTIVATOR LIGHT | Johnson & Johnson Professionals, Inc. | EBZ | Class II | 1978-01-03 |
| K772256 | CROWN & BRIDGE ALLOY | Johnson & Johnson Professionals, Inc. | EJH | Class II | 1978-01-03 |
| K772300 | DENTAL CHAIR, VANGUARD | Ritter Co. | KLC | Class I | 1978-01-03 |
| K772315 | KWIKAP | Den-Mat Corp. | EMB | Class I | 1978-01-03 |
| K772126 | TEMP. BRIDGE, POSTERIOR 3-UNIT | Lee Pharmaceuticals | DYH | Class II | 1978-01-03 |
| K772211 | TEMP. ACRYLIC | Lactong Corp. | EBG | Class II | 1977-12-22 |
| K772184 | X-RAY SYSTEM FOR DENTAL APPLICATION | General Electric Co. | EAP | Class II | 1977-12-22 |
| K772164 | PANORAMIC X-RAY SYSTEM MODEL A | Sybron Corp. | EHD | Class II | 1977-12-02 |
| K771921 | HYDRON ROOT CANAL FILLING SYSTEM | National Patent Development Corp. | KIF | Class II | 1977-11-15 |
| K772087 | ULTRASONIC DENTURE CLEANER | Clairol, Inc. | EFT | Class I | 1977-11-14 |
| K771886 | ACCU-PAQUE | Williams Gold Refining Co., Inc. | EIH | Class II | 1977-11-14 |
| K771887 | ACCU-STAIN | Williams Gold Refining Co., Inc. | EIH | Class II | 1977-11-14 |
| K771973 | GINGITRACT | Den-Mat Corp. | EIG | Class I | 1977-11-07 |
| K771908 | ISO-SHIELD SALIVA ABSORBERS | 3M Company | KHR | Class I | 1977-11-07 |
| K771938 | ALGINATE IMPRESSION MATERIAL | The S. S. White Co. | ELW | Class II | 1977-11-02 |
| K771852 | NIMETIC POLISHING PASTE | Espe GmbH (Us) | EJR | Class I | 1977-11-02 |
| K771873 | VISION SERIES DENTAL CHAIR | Chayes Virginia, Inc. | KLC | Class I | 1977-10-25 |
| K771883 | REPLICA ACID-ETCH | Hoyt Laboratories | DYH | Class II | 1977-10-20 |
| K771858 | EXPAND. RETENTION ENDOSSEOUS IMPLANT | A.L. Miller, Inc. | DZE | Class II | 1977-10-20 |
| K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE | Hoyt Laboratories | EBF | Class II | 1977-10-20 |
| K771890 | PERCEPTION SERIES DELIVERY SYS. | Chayes Virginia, Inc. | EIA | Class I | 1977-10-20 |
| K771889 | UNIOLITE | Espe Dental Products | EBZ | Class II | 1977-10-20 |
| K771901 | CAPMIX | Espe Dental Products | EFD | Class I | 1977-10-20 |
| K771880 | REPLICA DENTAL COMPOSIT | Hoyt Laboratories | EBF | Class II | 1977-10-20 |
12,679 clearances in the Dental panel. Data: openFDA.