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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.