meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
53
Latest Decision
1981-01-28

Clearances · page 122 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K803289 ARTUS DRILL #4000 Jedmed Instrument Co. DZI Class II 1981-01-28
K803288 ARTUS DRILL #6000 Jedmed Instrument Co. DZI Class II 1981-01-28
K803316 ORTHODONTIC BRACKET Orec Corp. EJF Class I 1981-01-14
K803310 CERAMCO PORCELAIN Johnson & Johnson Professionals, Inc. EIH Class II 1981-01-14
K802975 ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dentsply Intl. EBF Class II 1981-01-14
K803227 VISIO-DISPERS Espe-Premier Sales Co. EBF Class II 1981-01-14
K803209 ELIPAR LIGHT SOURCE Espe-Premier Sales Co. EBZ Class II 1981-01-14
K803129 GO-BETWEEN Agri Hort JES Class I 1981-01-08
K803155 PROPHYLAXIS CUP. Teledyne Densco EHK Class I 1981-01-08
K802984 MEISINGER DIAMOND DENTAL BURS Swiss American Metal Craft Corp. DZP Class I 1980-12-30
K802987 JOTA DIAMOND DENTAL BURS Swiss American Metal Craft Corp. DZP Class I 1980-12-30
K802989 MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. Swiss American Metal Craft Corp. EJL Class I 1980-12-30
K802967 DISPERSALLOY-DISPERSED PHASE ALLOY SELF- Johnson & Johnson Professionals, Inc. DZS Class I 1980-12-30
K802988 JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS Swiss American Metal Craft Corp. EJL Class I 1980-12-30
K802899 CERAMIBOND Zulauf, Inc. DYW Class II 1980-12-19
K802926 SCI-PHARM UNIVERSAL CAVITY VARNISH Scientific Pharmaceuticals, Inc. LBH Class II 1980-12-19
K802535 HYDROXYLATE DENTAL COMPOSITE RESTROATIVE Wallace A. Erickson & Co. EBF Class II 1980-12-18
K802679 SILANIT Vivadent (Usa), Inc. EBG Class II 1980-12-17
K801535 LARES HANDPIECE OIL Lares Manufacturing Co., Inc. EFB Class I 1980-12-16
K802662 POLYCARBONATE TEMPORARY CEMENT Buffalo Dental Mfg. Co., Inc. EMA Class II 1980-12-16
K802684 HELIOMAT Vivadent (Usa), Inc. EAY Class I 1980-11-24
K802681 HELIOBOND Vivadent (Usa), Inc. KLE Class II 1980-11-24
K802811 MONOJECT ROOT CANAL FILLING MAT. NEEDLE Sherwood Medical Co. DZM Class I 1980-11-24
K802682 CONTACT SEAL Vivadent (Usa), Inc. EBC Class II 1980-11-24
K802683 HELIOSIT Vivadent (Usa), Inc. EBF Class II 1980-11-24
K802819 KETAC-CEM IN REF. TO K802048 Espe Dental Products EMA Class II 1980-11-24
K802490 REIGNING DENTURE Oki Shiks USA , Ltd. EBI Class II 1980-11-19
K801927 SILENTSLEEP Slumber Research, Inc. DYN Class I 1980-11-14
K802483 LIGMAJECT Alan J. Khedarri D.D.S., Inc. EJI Class II 1980-11-12
K802489 REIGNING CROWN BRIDGE Oki Shiks USA , Ltd. EBG Class II 1980-11-12
K802680 ISOPAST-DS Vivadent (Usa), Inc. EBF Class II 1980-11-12
K802333 INSTANT BRIDGE Scientific Pharmaceuticals, Inc. KLE Class II 1980-11-12
K802491 REIGNING REPAIR EPOXY RESIN Oki Shiks USA , Ltd. EBI Class II 1980-11-12
K802492 REIGNING ARTIFICIAL TEETH Oki Shiks USA , Ltd. ELM Class II 1980-11-12
K802685 REOLIT Vivadent (Usa), Inc. EJK Class II 1980-11-12
K802515 ROOT CANAL POST Unitek Corp. ELR Class I 1980-11-12
K802562 PRISMA SEAL Dentsply Intl. EBC Class II 1980-11-12
K802716 DEN-MAT FIBER OPTIC HALOGEN LIGHT Den-Mat Corp. EAY Class I 1980-11-12
K802751 P-10 POSTERIOR FILLING MATERIAL 3M Company EBH Class I 1980-11-12
K801974 ANALYTIC TECH. METAL POINT HEATER #3001 Analytic Technology ELA Class I 1980-11-12
K802595 ERGO IRRIGATION SYSTEM Ergo Instruments, Inc. EFS Class I 1980-11-12
K802429 COTTON ROLLS Worldwide Surgical Gauze EFN Class I 1980-10-23
K802362 ALGINATE IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1980-10-10
K801860 S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX Pennwalt Corp. EJK Class II 1980-10-10
K802285 OHIO THORACIC SUCTION REGULATOR Ohio Medical Products KOP Class I 1980-10-03
K802235 MICRO-BOND HI-LIFE PROCELAIN & VIVERE Howmedica Corp. EIH Class II 1980-09-26
K802189 DENTLOID U.S. Shizai Corp. ELW Class II 1980-09-26
K801588 CAULK PRISMA-LITE Dentsply Intl. EBZ Class II 1980-09-16
K802125 ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dentsply Intl. EBF Class II 1980-09-16
K802049 NIMETIC-DISPERS Espe Dental Products EBF Class II 1980-09-16
K801689 SONATRON ULTRASONIC DENTAL SCANNER Simplified Systems, Inc. ELC Class II 1980-09-16
K801975 LITTLE GIANT I & II HANDPIECE CONTROL Silverman'S EIA Class I 1980-09-09
K801639 PERMITE DENTAL AMALGAM ALLOY Southern Dental Industries, Inc. EJJ Class II 1980-08-27
K801911 HOWMEDICA BITE BLOCK Howmedica Corp. EGD Class I 1980-08-27
K801888 HANDPIECE, DENTAL Aesculap Instruments Corp. DZA Class I 1980-08-20
K801886 BURR, DENTAL Aesculap Instruments Corp. EJL Class I 1980-08-20
K801887 DRILL, DENTAL Aesculap Instruments Corp. DZA Class I 1980-08-20
K801809 ORTHODONTIC BRACKET/SPEED/HANSON SPEED Strite Industries , Ltd. EJF Class I 1980-08-13
K801853 PARALLEL-A-PREP C.D. Charles, Inc. EGI Class I 1980-08-13
K801690 VALIANT L.D. Caulk Co. EJJ Class II 1980-08-13
K801651 CUTTER JET Cutter Laboratories, Inc. EFB Class I 1980-08-13
K801227 SILICAP Vivadent (Usa), Inc. EMA Class II 1980-08-12
K801142 PALODENT MATRICES & BITINE RINGS Alvin Meyer, D.D.S. DZN Class I 1980-08-07
K801732 PRISMA-FIL Dentsply Intl. EBF Class II 1980-08-07
K801780 OXY CUSTOM TRAY RESIN Oxy Dental Products, Inc. EBH Class I 1980-08-07
K801797 SCI-PHARM PAINT-ON RESTORATIVE Scientific Pharmaceuticals, Inc. EBF Class II 1980-08-07
K801798 COMPOSITE RESTORATIVE, PASTE/PASTE TYPE Scientific Pharmaceuticals, Inc. EBF Class II 1980-08-07
K801779 OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT Oxy Dental Products, Inc. EMB Class I 1980-08-07
K801529 KERR CORE COMPOSITE Sybron Corp. EBF Class II 1980-08-04
K801683 LUNA-VUE DENTAL OPERATING LIGHT Pacific Dental Corp. EAZ Class I 1980-08-04
K801688 TORX HANDPIECE CONTRA ANGLES ATTACHMENTS Pacific Dental Corp. EGS Class I 1980-08-04
K801686 SPACELINE THREE WAY SYRINGE Pacific Dental Corp. ECB Class I 1980-08-04
K801685 SPACELINE DENTAL CHAIR-UNIT Pacific Dental Corp. EIA Class I 1980-08-04
K801682 SPACELINE HIGH VOLUME EVACUATION HANDPIE Pacific Dental Corp. EHZ Class I 1980-08-04
K801687 TORX MICRO-MOTOR LOW SPEED HANDPIECE Pacific Dental Corp. EKX Class I 1980-08-04
K801530 COREFORM MOLDS Sybron Corp. DZN Class I 1980-07-28
K801591 FIBER OPTIC ILLUMINATOR Lares Manufacturing Co., Inc. EAY Class I 1980-07-21
K801548 PERF-LOCK IMPRESSION TRAY Dentsply Intl. EHY Class I 1980-07-21
K801483 MARK IV SYRINGE National Patent Development Corp. EIC Class I 1980-07-21
K801277 GDC 934 Deringer-Ney, Inc. EJS Class II 1980-07-21
K801525 ZEST ENDODONTIC STABILIZER Zest Anchors, Inc. ELS Class II 1980-07-21
K801524 ZEST PLANT Zest Anchors, Inc. DZE Class II 1980-07-21
K801592 FIBER OPTIC HOSE Lares Manufacturing Co., Inc. EAY Class I 1980-07-21
K801482 HYDRON ROOT CANAL FILLING MATERIAL National Patent Development Corp. KIF Class II 1980-07-21
K801463 OJ-1 ENDODONIC ROOT CANAL FILE HOLDER Almore Intl., Inc. EKQ Class I 1980-07-21
K801587 ASH BLUEPRINT ALGINATE IMPRESSION MATER. Dentsply Intl. ELW Class II 1980-07-21
K801484 ROOT CANAL FILLING APPLICATOR NEEDLES National Patent Development Corp. EIC Class I 1980-07-21
K801534 LARES AIR PRESSURE GAUGE Lares Manufacturing Co., Inc. EIA Class I 1980-07-14
K801236 REIGNING EPOXY RESIN CEMENT Oki Shiks USA , Ltd. EMA Class II 1980-07-08
K801380 CROWN DELTA SILICONE IMPRESSION MATERIAL Crown Delta Corp. ELW Class II 1980-07-08
K801342 DISPOSABLE ARTICULATOR Williams Gold Refining Co., Inc. EJP Class I 1980-07-08
K801235 REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN Oki Shiks USA , Ltd. ELM Class II 1980-06-20
K801225 DEN-MAT POLISHING PASTE Den-Mat Corp. EJR Class I 1980-06-17
K801274 S.S. WHITE-PENNWALT PRELUDE PIT SEALANT Pennwalt Corp. EBC Class II 1980-06-09
K801237 REIGNING CROWN-BRIDGE/POLYCARB. RESIN Oki Shiks USA , Ltd. EBF Class II 1980-06-09
K801234 REIGNING DENTURE MADE OF POLYCARB. RESIN Oki Shiks USA , Ltd. EBI Class II 1980-06-09
K801009 HOWMEDICA WHITE C&B ALLOY Dental Laboratory Products Div. EJS Class II 1980-06-04
K801229 BONDALCAP (CARBOXYLATE) Vivadent (Usa), Inc. EMA Class II 1980-06-04
K801228 BONDALCAP (SILICO-PHOSPHATE) Vivadent (Usa), Inc. EMA Class II 1980-06-04
K801216 DEN-MAT DENTIN BONDING AGENT Den-Mat Corp. KLE Class II 1980-05-28

12,679 clearances in the Dental panel. Data: openFDA.