meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
44
Latest Decision
1986-08-01

Clearances · page 112 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862523 MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS Walter Lorenz Surgical, Inc. EKW Class I 1986-08-01
K862660 PRISMA METAL OPAQUERS Dentsply Intl. EBC Class II 1986-07-31
K862667 COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY Austenal Dental, Inc. EJH Class II 1986-07-31
K862745 EUGENOL USP E&D Dental Manufacturing Co. EMB Class I 1986-07-31
K862695 FLUOR-ETCH GEL ETCHANT Teledyne, Inc. EBC Class II 1986-07-31
K862061 OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 Coors Biomedical Co. LYC Class II 1986-07-29
K862232 PANAVIA TC, AND PANAVIA OPAQUE Kuraray Co. EBF Class II 1986-07-29
K862482 STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS Walter Lorenz Surgical, Inc. JEY Class II 1986-07-25
K862449 DEN-MAT DENTIN LINK Den-Mat Corp. EBF Class II 1986-07-22
K862590 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) 3M Company EBD Class II 1986-07-22
K862129 SET CANAL SEALER PASTE Endo Technic Corp. EKM Class I 1986-07-22
K862648 V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT Scientific Pharmaceuticals, Inc. EBF Class II 1986-07-18
K862558 AUSTENAL ACUPAC HI DENTURE BASE MATERIAL Austenal Dental, Inc. EBI Class II 1986-07-18
K862139 IMTECH FIXATION SYSTEMS Imtech, Inc. JEY Class II 1986-07-16
K862538 SENTRY BREAKWAY NECK STRAP Ormco Corp. DZB Class II 1986-07-11
K861727 COTTON FILLED GAUZE SPONGES 2 X 2 Cross Country Paper Products Corp. EFN Class I 1986-07-10
K861833 RESTOR (COMET)*DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1986-07-09
K862417 NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY Austenal Dental, Inc. EJH Class II 1986-07-03
K860835 CEPHALOSTAT Dallas Dental Co. EHD Class II 1986-07-01
K860264 SCHERER PORTABLE TOOTH POLISHER Scherer Laboratories, Inc. JEQ Class I 1986-06-26
K861502 EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM Dr. Harold Bergman DZE Class II 1986-06-26
K861846 HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT Solar Dental Co., Inc. EIC Class I 1986-06-26
K861899 SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE 3M Company EBF Class II 1986-06-25
K862284 SEALITE Sybron Corp. EBC Class II 1986-06-23
K862280 SHOFU LINING CEMENT Shofu Dental Corp. EMA Class II 1986-06-23
K860855 SHUR GEL 4 Columbus Dental Mfg. Co. ELW Class II 1986-06-16
K854765 INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH C&C Systems, Inc. EHP Class I 1986-06-13
K861820 BIOSIL F Degussa Dental, Inc. EJH Class II 1986-06-13
K861934 SALIVA EJECTOR Carlisle Laboratories, Inc. DYN Class I 1986-06-09
K861965 UNITEK CERAMIC BRACKET SYSTEM Unitek Corp. DYW Class II 1986-06-09
K854647 POLO DENTAL UNIT Alpine Dental Equipment Co. KLC Class I 1986-06-05
K861041 ENHANCE Packaging Technologies, Inc. LYC Class II 1986-05-30
K860487 URENAMEL, POSTERIOR RESTORATIVE MATERIAL Cadco Dental Products, Inc. EBF Class II 1986-05-30
K861424 ADAPTABLE CLASS III MASK Great Lakes Orthodontics, Ltd. DZB Class II 1986-05-29
K860983 INTERPORE 200 POROUS HYDROXYAPATITE Interpore Intl. LYC Class II 1986-05-23
K861740 P-50 LIGHT CURED RESIN BONDED CERAMIC 3M Company EBF Class II 1986-05-21
K861787 BIOSIL H Degussa Dental, Inc. EJH Class II 1986-05-21
K861561 ZEST MARK II (STANDARD & MINI) Zest Anchors, Inc. EGG Class I 1986-05-21
K861546 REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT Macrochem Corp. EBF Class II 1986-05-21
K860843 CHECK-UP PLAQUE FIGHTING GUM Minnetonka, Inc. EJR Class I 1986-05-21
K861685 SUPERLON (UNILON) CARBOXYLATE CEMENT Carlisle Laboratories, Inc. EMA Class II 1986-05-19
K854299 GORE-TEX PERIODONTAL MATERIAL W. L. Gore & Associates, Inc. NPK Class II 1986-05-19
K854995 DENCLENZ Creighton Products Corp. EFT Class I 1986-05-12
K854692 MONARCH II BLEACHING INSTRUMENT Almore Intl., Inc. EEG Class I 1986-05-12
K861581 CENTRIX PCR MOLAR MATRIX FORMS (BANDS) Centrix, Inc. DZN Class I 1986-05-12
K861118 ORTHOJOIN, ORTHODONTIC ADHESIVE Ortho Source DYH Class II 1986-05-02
K861084 OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH Coors Biomedical Co. LYC Class II 1986-04-30
K861148 BISCO'S PORCELAIN VENEER SYSTEM Bisco, Inc. EBF Class II 1986-04-30
K861083 OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH Coors Biomedical Co. LYC Class II 1986-04-30
K861005 GLASIONOMER BASE CEMENT Shofu Dental Corp. EMA Class II 1986-04-25
K860982 DB PRECISION IMPLANT SYSTEM, 2000 SERIES Driskell Bioengineering DZE Class II 1986-04-25
K861328 NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY Belmont Equipment Corp. EAP Class II 1986-04-24
K854326 NO FLOSS FLOSSER Rgm Assoc. JEQ Class I 1986-04-23
K853089 SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE Psp Dental Co., Ltd. ELW Class II 1986-04-21
K860708 PHOTO CLEARFIL OPAQUER Kuraray Co. EBF Class II 1986-04-17
K861258 PERMABAND (ORTHODONTIC ADHESIVE) Ortho Source DYH Class II 1986-04-17
K860118 SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 Northern Electric Co. Div. of Sunbeam Corp. EFT Class I 1986-04-17
K860653 PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT Otc/America DZE Class II 1986-04-17
K861239 ACRYLIC SOLDER Parker Laboratories, Inc. EBI Class II 1986-04-17
K861245 ORTHOSOURCE ETCH SYSTEMS Ortho Source EBC Class II 1986-04-11
K861150 EXEL DENTAL NEEDLE Exel Intl. DZM Class I 1986-04-11
K860633 FLUOROSEAL, DENTIN SEALER AND CAVITY LINER Scientific Pharmaceuticals, Inc. LBH Class II 1986-04-11
K860626 NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID Scientific Pharmaceuticals, Inc. EBF Class II 1986-04-08
K853094 EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA Psp Dental Co., Ltd. EBI Class II 1986-04-04
K860360 KYOCERA BIOCERAM POROUS DENTAL IMPLANT Kyocera International, Inc. DZE Class II 1986-04-04
K853092 PSP C & B TEMP Psp Dental Co., Ltd. EBG Class II 1986-04-03
K860779 ULTRAPROX, INTERPROXIMAL TOOTHBRUSH William J. Forni, D.D.S. JET Class I 1986-04-02
K860963 'E-Z FLOSS' AND 'LAZY FLOSS' Login Industries , Ltd. JES Class I 1986-03-26
K860911 AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL Austenal Dental, Inc. ELW Class II 1986-03-26
K854828 SCI-PRO, PROPHYLAXIS PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1986-03-26
K860769 DENTAL FLOSS HOLDER Sewon Industry JES Class I 1986-03-26
K860964 WHITE SILVER SOLDER AND YELLOW SILVER SOLDER Austenal Dental, Inc. EJS Class II 1986-03-26
K860569 ENDODONTIC ROOT CANAL PLUGGER Dentsply Intl. EKR Class I 1986-03-26
K860324 DENTAL FLOSS CARD Washburn Laboratories JES Class I 1986-03-26
K854696 OP II VISIBLE LIGHT CURING SYSTEM Almore Intl., Inc. EBZ Class II 1986-03-26
K860608 ARTIFICIAL TEETH, PORCELAIN, MODIFIED Dentsply Intl. ELL Class II 1986-03-26
K860627 SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE Scientific Pharmaceuticals, Inc. EBF Class II 1986-03-26
K860737 TEEN CLEAN, RETAINER CLEANER Teen Care, Inc. EFT Class I 1986-03-26
K860971 DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) Den-Mat Corp. KLE Class II 1986-03-25
K860959 DEPENDABOND Ortho Source DYH Class II 1986-03-25
K854829 DENSCO PROPHY PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1986-03-25
K860346 KERR PORCELITE Kerr Corporation (Danbury) KLE Class II 1986-03-25
K854690 DIAMONDS BURS-COMPOSIT FINISHING Almore Intl., Inc. EJL Class I 1986-03-25
K854691 DIAMOND BURS-HANDPIECE Almore Intl., Inc. EJL Class I 1986-03-25
K855182 ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65 Williams Gold Refining Co., Inc. EJS Class II 1986-03-25
K860532 KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL Kerr Corporation (Danbury) ELW Class II 1986-03-20
K860439 DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS Williams Gold Refining Co., Inc. EJS Class II 1986-03-20
K860817 ROOT CANAL ORGANIZER Pacific Union Dental, Inc. EIK Class I 1986-03-17
K860119 GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS) Deringer-Ney, Inc. EJS Class II 1986-03-17
K854106 BAYSILEX Cutter Laboratories, Inc. ELW Class II 1986-03-17
K860299 REALOR ALLOY Degussa Dental, Inc. EJS Class II 1986-03-17
K860146 POLYJEL N.F. (NEW FORMULA) Dentsply Intl. ELW Class II 1986-03-17
K853529 IMPREGUM-F Espe GmbH (Us) ELW Class II 1986-03-17
K860217 NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY) Austenal Dental, Inc. EJH Class II 1986-03-17
K860437 PARTIAL DENTURE ALLOY Dentsply Intl. EJH Class II 1986-03-17
K854643 SOLAR Alpine Dental Equipment Co. EIA Class I 1986-03-14
K854642 SOLAR CART Alpine Dental Equipment Co. EIA Class I 1986-03-14
K854168 TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES Travenol Laboratories, S.A. ELA Class I 1986-03-13
K854755 RENAMEL ESTHETIC RESTORATIVE SYSTEM Cosmedent, Inc. EBF Class II 1986-03-13
K855211 PANAVIA EX, A DENTAL ADHESIVE Kuraray Co. EMA Class II 1986-03-13

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