Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 47
- Latest Decision
- 1984-02-21
Clearances · page 117 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K834435 | CROWN & BRIDGE RESIN | Rohm and Haas Co. | EBI | Class II | 1984-02-21 |
| K832647 | ARTICULATING PAPER | Ardent Intl., Inc. | EFH | Class I | 1984-02-21 |
| K834072 | INSTRUMENT, DENTAL | Venture Technology, Inc. | EMS | Class I | 1984-02-21 |
| K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1984-02-21 |
| K834606 | X-RAY COLLIMATOR X-CJD | Knochen Dental Laboratory | EHB | Class I | 1984-02-21 |
| K834247 | MATERIAL TOOTHSADE RESIN | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1984-02-10 |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | EFH | Class I | 1984-02-10 |
| K833815 | ZACT DENTAL ARCH TOOTHBRUSCH | Jfc International, Inc. | EFW | Class I | 1984-02-10 |
| K834580 | REACH* TOOTHBRUSH | Johnson & Johnson Professionals, Inc. | EFW | Class I | 1984-02-10 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. | EFN | Class I | 1984-02-03 |
| K834046 | LUXENE VINYL-JECT 3600-80 | Howmedica Corp. | EBF | Class II | 1984-02-03 |
| K834272 | ALEXOLOK BRACKET | Alexotek Co. | EJF | Class I | 1984-02-03 |
| K833757 | VISIO-GEM | Espe GmbH (Us) | EBF | Class II | 1984-02-03 |
| K833788 | FILAFEX ESTHETIC ORTHODINIC WIRE | Berkley and Co. | DZC | Class I | 1984-01-24 |
| K833774 | NATURELLE II & LITE II-N72-N74-L | Jeneric Ind. | EJS | Class II | 1984-01-24 |
| K833701 | ACA THYROXINE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | LBH | Class II | 1984-01-13 |
| K833558 | X-RAY SHIELD | Moyco Industries, Inc. | EHB | Class I | 1984-01-13 |
| K833426 | DOCTOR VELLETTE'S INJECTOR | Deproco, Inc. | EJI | Class II | 1984-01-13 |
| K833455 | REMOLDABLE CRANIOMANDIBULAR APPLIANCE | Jeffrey H. Attlin | KMY | Class I | 1984-01-10 |
| K833610 | DENTAL RUBBERDAM | Center For Marketing Services | EIE | Class I | 1984-01-10 |
| K833006 | CEPHALOMETER & FIXATOR | Modern Systems, Inc. | EAG | Class II | 1984-01-03 |
| K833287 | SATIN CAST ECONOCAST | Genesis Industries, Inc. | EIS | Class I | 1984-01-03 |
| K833290 | C & B 40 PENTRO C & B40 | Genesis Industries, Inc. | EIS | Class I | 1984-01-03 |
| K833955 | NOVEL DISPENSER/PACKAGE | Dentsply Intl. | EIY | Class I | 1984-01-03 |
| K833261 | INTERIM TEMP. CROWN & BRIDGE RESIN | Coe Laboratories, Inc. | EBG | Class II | 1984-01-03 |
| K833643 | CRYSTAR PORCELAIN | Shofu Dental Corp. | EIH | Class II | 1983-12-29 |
| K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. | EJL | Class I | 1983-12-29 |
| K833289 | C & B 61 PENTRON C & B61 | Genesis Industries, Inc. | EIS | Class I | 1983-12-29 |
| K833596 | GDC 1448 DEVELOPMENT NAME | Deringer-Ney, Inc. | EJS | Class II | 1983-12-29 |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | EIS | Class I | 1983-12-29 |
| K833434 | CERAMCO * HIGH FUSING FOIL SOLDER | Johnson & Johnson Professionals, Inc. | EJS | Class II | 1983-12-29 |
| K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY | Belmont Equipment Corp. | EAP | Class II | 1983-12-29 |
| K833278 | C & B 45 | Genesis Industries, Inc. | EIS | Class I | 1983-12-29 |
| K833718 | ETCHING GEL | Johnson & Johnson Professionals, Inc. | KLE | Class II | 1983-12-29 |
| K833512 | PARTIAL DENTURE ALLOY | Dentsply Intl. | EJH | Class II | 1983-12-27 |
| K833473 | DENTIN BONDING AGENT | Johnson & Johnson Professionals, Inc. | KLE | Class II | 1983-12-27 |
| K833445 | DEGUPLUS 2 | Degussa Dental, Inc. | EJS | Class II | 1983-12-26 |
| K833280 | SUPRA AP CHOICE 83 | Genesis Industries, Inc. | EIS | Class I | 1983-12-26 |
| K833485 | IMPRESSION TUBE ADJUSTABLE | Zefr, Inc. | EHY | Class I | 1983-12-26 |
| K833429 | PERI MIRROR/SALIVA EJECTOR | Dentec, Inc. | EAX | Class I | 1983-12-22 |
| K833285 | RX IV PENTRON IV | Genesis Industries, Inc. | EIS | Class I | 1983-12-22 |
| K833288 | C & B57 PENTRON C & B57 | Genesis Industries, Inc. | EIS | Class I | 1983-12-20 |
| K833143 | REXILLIUM III | Jeneric Ind. | EJH | Class II | 1983-12-08 |
| K832509 | MBS HARD TISSUE REPLACEMENT SYSTEM | Medical Biological Sciences, Inc. | LYC | Class II | 1983-11-29 |
| K833279 | NATURELLE-LITE | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833281 | RX D PENTRON | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833284 | RX 41 PENTRON 41 | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833145 | ZENITH | Jeneric Ind. | EJH | Class II | 1983-11-28 |
| K833283 | RX ORY PENTRON C & B | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833282 | RX NYSP PENTRON 60 | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833286 | RX SEG ECONOPLUS | Genesis Industries, Inc. | EIS | Class I | 1983-11-28 |
| K833338 | TOOTH SLOOTH | Joel Lander D.D.S. | EJB | Class I | 1983-11-25 |
| K833052 | RXG | Jeneric Ind. | EJT | Class II | 1983-11-14 |
| K833053 | Y CERAMIC | Jeneric Ind. | EJT | Class II | 1983-11-14 |
| K831351 | PERMALUX VISIBLE CURE COMPOSITE RESTOR | Lares Manufacturing Co., Inc. | EBF | Class II | 1983-11-14 |
| K833241 | INTREX | Pennwalt Corp. | EAP | Class II | 1983-10-28 |
| K833049 | PALLADENT | Jeneric Ind. | EJS | Class II | 1983-10-28 |
| K833144 | REX ALLOY | Jeneric Ind. | EJH | Class II | 1983-10-28 |
| K833050 | RX 90 | Jeneric Ind. | EJS | Class II | 1983-10-28 |
| K832500 | CS-11 | Chema-Scutum, Inc. | EBE | Class II | 1983-10-27 |
| K832665 | SATELEC SUPRASSON SP 3055 | Spelna, Inc. | ELC | Class II | 1983-10-19 |
| K832673 | SATELEC PROPHY UNIT PU-2000 | Spelna, Inc. | EIA | Class I | 1983-10-19 |
| K832781 | CURAY-SUPPORT, CORE BUILD-UP MATERIAL | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1983-10-19 |
| K832662 | DENTAL SYRINGE SYSTEM-VARIOUS STYLES | Centrix, Inc. | KXR | Class I | 1983-10-04 |
| K833039 | HANDY IIM | Shofu Dental Corp. | EJP | Class I | 1983-10-04 |
| K833038 | SUMMA DISK | Shofu Dental Corp. | DZP | Class I | 1983-10-04 |
| K832179 | HOT PROBE MODEL 6001 | Analytic Technology | EEG | Class I | 1983-10-04 |
| K832425 | GREAT LAKES PASTE SOLDER | Great Lakes Orthodontics, Ltd. | EJS | Class II | 1983-10-04 |
| K832497 | CAVITY CLEANSER | Den-Mat Corp. | LBH | Class II | 1983-10-04 |
| K832949 | SANODENT DOUBLE-ENDED INTERDENTAL CLEAN | Coopercare, Inc. | JET | Class I | 1983-10-04 |
| K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Dental Corp. | DZP | Class I | 1983-10-04 |
| K832378 | VIBRATORY ENDODONTIC SYSTEM | Syntex Dental Products, Inc. | EKQ | Class I | 1983-10-04 |
| K832855 | TPE DIAMOND POINTS | Shofu Dental Corp. | DZP | Class I | 1983-09-29 |
| K832834 | CONCISE 2 SMALL PARTICLE LIGHT CURVED | 3M Company | EBD | Class II | 1983-09-29 |
| K832530 | DEVA 4 | Degussa Dental, Inc. | EJS | Class II | 1983-09-29 |
| K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | JER | Class I | 1983-09-26 |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | EKM | Class I | 1983-09-26 |
| K832286 | CERESTORE CORE MATERIAL | Johnson & Johnson Professionals, Inc. | EIH | Class II | 1983-09-26 |
| K832366 | ZOLLER BURNED LIP CONFORMER | Universal Prosthetics, Inc. | EIG | Class I | 1983-09-26 |
| K831215 | DENTACOLOR LIGHT CURING CROWN & BRIDGE | Kulzer, Inc. | EBF | Class II | 1983-09-12 |
| K831077 | DENTALON | Kulzer, Inc. | EBG | Class II | 1983-09-12 |
| K832443 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | California Technics, Inc. | ELC | Class II | 1983-09-12 |
| K832065 | ACURACY 071, DENTAL, INTRAORAL-X-RAY | Belmont Equipment Corp. | EAP | Class II | 1983-09-12 |
| K832387 | DENTURE CLEANER | Tower Laboratories, Ltd. | JER | Class I | 1983-09-12 |
| K832292 | SOLO-TACH | Dentsply Intl. | DYH | Class II | 1983-09-01 |
| K832062 | ADAPTIC*FAST SET DENTAL RESTORATIVE | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1983-08-31 |
| K831095 | ROYALE II | Factor, Ii, Inc. | EBI | Class II | 1983-08-31 |
| K832320 | PRISMA III | Dentsply Intl. | EBZ | Class II | 1983-08-31 |
| K832291 | AUTO-TACH | Dentsply Intl. | DYH | Class II | 1983-08-31 |
| K832061 | LIGHT CURING BONDING AGENT | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1983-08-31 |
| K832222 | PRO PULSE PERIODONTAL IRRIGATOR 7618 | Vipont Laboratories, Inc. | EFS | Class I | 1983-08-31 |
| K832223 | PERIODONTAL IRRIGATOR #7620 | Vipont Laboratories, Inc. | EFS | Class I | 1983-08-31 |
| K831294 | SOLARCRY/TEMPORARY CROWN & BRIDGE MAT | Solar Dental Co., Inc. | EBG | Class II | 1983-08-31 |
| K832253 | X-704 | Unitek Corp. | EJS | Class II | 1983-08-31 |
| K832112 | NO-MIX 30 ORTHODONTIC BONDING SYSTEM | Scientific Pharmaceuticals, Inc. | DYH | Class II | 1983-08-31 |
| K830763 | FR ROOT CANAL FILLER | Shizai Corp. | KIF | Class II | 1983-08-26 |
| K832063 | ROBIN CORDLESS HANDPIECE | Kaycor Intl., Ltd. | EKX | Class I | 1983-08-26 |
| K831976 | POWER OPTIC | Ritter Co. | EAY | Class I | 1983-08-12 |
| K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | KMY | Class I | 1983-08-12 |
| K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S | EAY | Class I | 1983-08-11 |
12,679 clearances in the Dental panel. Data: openFDA.