meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
49
Latest Decision
1985-04-08

Clearances · page 115 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850824 PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST Kuraray Co. EBF Class II 1985-04-08
K850821 CERESTORE DENTIN PORCELAIN Johnson & Johnson Professionals, Inc. EIH Class II 1985-04-08
K844670 KORVIN VITA RADIOPAQUE PLASTIC TEETH Credent Co. ELM Class II 1985-04-08
K844989 FLO-PHORESIS - DESENSITIZER Eastco, Inc. EGS Class I 1985-04-01
K850562 FLOSSAGE - ELECTRIC TOOTHFLOSSER Mcspadden, Inc. JEQ Class I 1985-03-27
K850344 AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG Midwest EGS Class I 1985-03-25
K844846 ESPE KETAC-CEM RADIOPAQUE Espe GmbH (Us) EMA Class II 1985-03-25
K850675 CURAY JOIN DENT DENTIN PRIMER Scientific Pharmaceuticals, Inc. EBD Class II 1985-03-25
K844867 DUALLOR R SOLDER Degussa Dental, Inc. EJT Class II 1985-03-25
K844662 KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI Kerr Corporation (Danbury) EBF Class II 1985-03-25
K844653 LIMI ALLOY G-C Intl. Corp. EJJ Class II 1985-03-25
K850597 MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL Micro-Aire Surgical Instruments, Inc. EFB Class I 1985-03-25
K850641 CAULK DYCAL LIGHT CURED Dentsply Intl. EBD Class II 1985-03-18
K850699 SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL Williams Gold Refining Co., Inc. EJS Class II 1985-03-18
K850776 PREFORMED DENTAL IMPRESSION TRAYS L.A.K. Ent., Inc. EHY Class I 1985-03-18
K845033 FOREMOST DENTIN ADHESIVE Foremost Dental Mfg., Inc. EBF Class II 1985-03-18
K845034 FOREMOST LITE CURE PIT & FISSURE SEALANT Foremost Dental Mfg., Inc. EBC Class II 1985-03-18
K842877 ABSOLUTE VINYL POLYSILOXANE IMPRESS Coe Laboratories, Inc. ELW Class II 1985-03-11
K844497 AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY Austenal Dental, Inc. EJH Class II 1985-02-27
K844635 HYDROSET ROOT CANAL SEALER Lund Manufacturing Co. KIF Class II 1985-02-19
K850103 GDC-1489 A CASTING ALLOY Deringer-Ney, Inc. EJS Class II 1985-02-08
K850101 GDC-1629 A CASTING ALLOY Deringer-Ney, Inc. EJS Class II 1985-02-08
K850073 J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT Johnson & Johnson Professionals, Inc. EBD Class II 1985-02-08
K844471 VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE Dentsply Intl. EBH Class I 1985-02-08
K850102 GDC-1433 A CASTING ALLOY Deringer-Ney, Inc. EJS Class II 1985-02-08
K844339 BRAUN DENTAL CENTER OC-3 The Braun Corp. EFS Class I 1985-02-08
K850036 COLTENE PRECISE Coltene, Inc. ELW Class II 1985-02-08
K850193 PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS) Degussa Dental, Inc. EJS Class II 1985-02-08
K844250 OSADA ENAC Osada Electric Co., Ltd. ELC Class II 1985-01-23
K844034 SONOCARE Echo Ultrasound DYO Class I 1985-01-23
K850014 HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE Medi-Dent American, Inc. EBH Class I 1985-01-23
K844572 PRE-KLENE ENAMEL CLEANER Medical Products Laboratories, Inc. EFT Class I 1985-01-18
K844395 RENAISSANCE Williams Gold Refining Co., Inc. EJT Class II 1985-01-09
K844123 RX CBY Jeneric Ind. EJH Class II 1985-01-09
K844394 RENAISSANCE BONDING AGENT Williams Gold Refining Co., Inc. EJT Class II 1985-01-09
K844122 RX CBG Jeneric Ind. EJH Class II 1985-01-09
K843017 ABSORBENT ENDODONTIC POINT United Dental Mfg., Inc. EKN Class I 1985-01-09
K844626 MINI FLOW- DENTAL FLOSS Mini Floss JES Class I 1985-01-09
K844308 PIT AND FISSURE SEAANTS Dentsply Intl. EBC Class II 1985-01-09
K844211 CONCISE LIGHT CURED WHITE SEALANT 3M Company EBC Class II 1985-01-07
K844438 SIMPLIFLOS DENTAL FLOSSER Valiant Steel & Equipment, Inc. JES Class I 1985-01-04
K844234 ACTIVE VERTICAL CORRECTOR APPLIANCE Active Vertical Correctors, Inc. ECO Class I 1985-01-04
K844133 CLEANSE N BOND I Lee Pharmaceuticals DYH Class II 1985-01-04
K844134 CLEANSE N BOND II Lee Pharmaceuticals DYH Class II 1985-01-04
K844457 SECURIPIN Hughes Int'L, Inc. EBL Class I 1984-12-27
K843398 OSTEOGEN Impladent LYC Class II 1984-12-27
K843550 ORTHOMAG MAGNETIC FORCE SYSTEM Medical Magnetics, Inc. ECO Class I 1984-12-21
K844351 OPTI-LITE Innovators, Inc. EBZ Class II 1984-12-21
K843406 CHEW-DENT Senair-Mot JEW Class I 1984-12-11
K844325 COE-LITE POLYMERIZATION UNIT Coe Laboratories, Inc. EBZ Class II 1984-12-11
K843566 KETAC-SILVER Espe GmbH (Us) EMA Class II 1984-12-06
K843823 TRANSLUX CL Kulzer, Inc. EBZ Class II 1984-12-04
K843344 ACTIVE VERTICAL CORRECTOR ACTIVE BITE Active Vertical Correctors, Inc. ECO Class I 1984-12-03
K844238 ORAPIK PERIODONTAL SCALER Dental Concepts, LLC JET Class I 1984-12-03
K842477 CREDENT RADIOPAQUE DENTURE RESIN Credent Co. EBI Class II 1984-12-03
K842476 CREDENT RADIOPAQUE CROWN & BRIDE Credent Co. EBI Class II 1984-12-03
K843171 FILAFEX TM, ESTHETIC ORTHODONTIC WIRE Berkley and Co. DZC Class I 1984-12-03
K843901 ISOSTATIC CONDENSER Shofu Dental Corp. EKG Class I 1984-12-03
K844349 SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS Ivoclar USA, Inc. ELM Class II 1984-12-03
K844329 SURFLEX F G-C Intl. Corp. ELW Class II 1984-12-03
K844057 C-22 PIT & FISSURE SEALANT Pentron Corp. EBC Class II 1984-12-03
K844326 OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE Coe Laboratories, Inc. EBF Class II 1984-12-03
K844324 TIGER BAND World Wide Outdoor Marketing DZN Class I 1984-12-03
K843557 K-APATITE 20-40 MESH K-APATITE 40-60 Katecho, Inc. ELE Class II 1984-11-30
K844292 MEDI-TECH DILATATION CATHETERS Medi-Tech, Inc. LCN Class I 1984-11-23
K844318 ORAL IRRIGATION TIP Pro Pulse, Inc. EFS Class I 1984-11-23
K844067 VANISH ORTHODONTIC BRACKET A Company, Inc. EJF Class I 1984-11-23
K844291 ARK TONGUE CLEANER Arkay Co. LCN Class I 1984-11-23
K843705 MANDIBULATOR JAW POSITIONER A Company, Inc. DYJ Class I 1984-11-14
K843951 SIROGNATHOGRAPH Siemens Medical Solutions USA, Inc. NFS Class I 1984-11-14
K843722 ORTHODONTIC WIRE Arthur L. Wool DZC Class I 1984-11-09
K842324 PERFOURM Cutter Laboratories, Inc. ELW Class II 1984-11-09
K843742 UNITEK CONVERTIBLE CAP REMOVER TOOL Unitek Corp. JEX Class I 1984-11-09
K842718 HYDROXYAPATITE Depuy, Inc. LYC Class II 1984-11-07
K842995 EMA LIV CENERA DENTAL CEMENT Int'L Corp. EMA Class II 1984-10-30
K843363 RESTODENT VL Lee Pharmaceuticals EBF Class II 1984-10-25
K843025 COMMAND ENAMEL-DENT DENTAL ADHESIVE Kerr Corporation (Danbury) KLE Class II 1984-10-25
K843233 ANATOM SYSTEM Lic-Orthion KLC Class I 1984-10-25
K843234 CITOMAT AUTOCLAVES Lic-Orthion ECG Class I 1984-10-25
K843023 KERR PORCELAIN REPAIR PRIMER Kerr Corporation (Danbury) KLE Class II 1984-10-25
K843145 TWO COMPONENT RTV VINYL SILICONE MATER Crown Delta Corp. ELW Class II 1984-10-18
K843527 ORTHOMITE 111 ADHESIVE Rocky Mountain Orthodontics, Inc. DYH Class II 1984-10-18
K842994 EMA FREEGENOL DENTAL CEMENT Int'L Corp. EMA Class II 1984-10-18
K843217 HOLLOW BASKET DENTAL IMPLANTS Artech Corp. DZE Class II 1984-10-15
K843154 TOOTH ROOT SOCKET GAUGE Interpore Intl. LYC Class II 1984-10-01
K843026 KERR GELLED PHOSPHORIC ACID ETCHANT Kerr Corporation (Danbury) EBF Class II 1984-09-27
K843436 DENTAL CHAIR Swedish Dental Products, Inc. KLC Class I 1984-09-27
K843143 STABILIZING RETAINER Dental Advancements, Inc. EJF Class I 1984-09-27
K842576 CLEAR LINER Harry J. Bosworth Co. EBI Class II 1984-09-27
K842448 BOSWORTH SUPER BOND DENTAL ADHESIVE Harry J. Bosworth Co. DYH Class II 1984-09-27
K843314 MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE Smith & Nephew, Mpl Division EJI Class II 1984-09-27
K843024 COMMAND ULTRASEAL PIT & FISSURE SEALANT Kerr Corporation (Danbury) EBC Class II 1984-09-27
K843018 FLEXI-POST Essential Dental Systems, Inc. ECR Class I 1984-09-27
K843153 ANTERIOR ALVEOLAR RIDGE SIZER Interpore Intl. LYC Class II 1984-09-27
K843218 TPS SCREW DENTAL IMPLANTS Artech Corp. DZE Class II 1984-09-27
K842357 PM 2000 DENTAL UNIT Planmeca USA, Inc. EIA Class I 1984-09-12
K843072 EVER-BOND V GLASS LONOMER RESTORATIVE Kerr Corporation (Danbury) EBF Class II 1984-09-07
K843098 APCO FISSURE SEALER & BONDING AGENT Scientific Pharmaceuticals, Inc. EBC Class II 1984-09-07
K843022 KERR COMMAND ULTRAFINE POLISHING PASTE Kerr Corporation (Danbury) EJR Class I 1984-08-24
K842844 DENTI-D RUBBER DAM Fema Corp. EIE Class I 1984-08-17

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