meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
44
Latest Decision
1993-01-11

Clearances · page 94 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K923384 ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED L.C. Dental EJJ Class II 1993-01-11
K925404 CLEARFIL PORCELAIN BOND ACTIVATOR Kuraray Co. KLE Class II 1993-01-11
K925712 RELIANCE SHORT STICK TIE Reliance Orthodontic Products, Inc. DYX Class II 1993-01-11
K923163 RUBBER DAM CLAMP Aseptico, Inc. EIE Class I 1992-12-28
K924151 BISCO D/C RESINOMER Bisco, Inc. EBF Class II 1992-12-28
K913724 SONEX ULTRASONIC TOOTH BRUSH Sonex Intl., Corp. JEQ Class I 1992-12-28
K922559 ACUFEX ENDOFIX BUTTON Acufex Microsurgical, Inc. EBG Class II 1992-12-24
K925032 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM 3M Company EMA Class II 1992-12-23
K921283 ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN Jeneric/Pentron, Inc. DYH Class II 1992-12-23
K923895 QUIKSEAL Mirage Dental Systems EBC Class II 1992-12-23
K922955 ZENON PLUS Jeneric/Pentron, Inc. EJS Class II 1992-12-23
K920684 NEW TOOTH MATERIAL Dentsply Intl. ELM Class II 1992-12-23
K922741 LORENZ 1.0 MM SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 1992-12-23
K923836 .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING Ultimate Wireforms, Inc. DZC Class I 1992-12-23
K923462 DELIGHT Planmeca USA, Inc. EAZ Class I 1992-12-21
K923461 PM2002 PROLINE, PM2002 PROLINE EC Planmeca USA, Inc. KLC Class I 1992-12-21
K925273 GDC 3445 Deringer-Ney, Inc. EJS Class II 1992-12-21
K922437 HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 Dabi-Atlante America Corp. EFB Class I 1992-12-21
K923556 ADP FACEMASK Ormco Corp. DZB Class II 1992-12-04
K921776 1840 HA PARTICLES Bio-Interfaces, Inc. LYC Class II 1992-12-04
K922774 COLLEGIATE J.F. Jelenko & Co., Inc. EJT Class II 1992-12-04
K923838 THE ULTIMATE RCS ARCH WIRE Ultimate Wireforms, Inc. DZC Class I 1992-12-04
K922790 DEGUCAST 40 Degussa AG EJH Class II 1992-12-03
K923261 ORTHODONTIC METAL BRACKET American Orthodontics EJF Class I 1992-12-03
K924130 COFFMAN IMPLANT TOMOGRAPH Coffman Dental EHD Class II 1992-11-27
K923067 SENS-A-RAY Regam Medical Systems EHD Class II 1992-11-27
K924812 3M CURING LIGHT XL 3000 3M Company EBZ Class II 1992-11-25
K924993 GLENROE BAND SEATING CONTOURING INSTRUMENT Glenroe Technologies ECS Class I 1992-11-25
K921748 MODEL 2000 DENTAL AIR ABRASIVE SYSTEM Texas Airsonics, Inc. KOJ Class II 1992-11-25
K924645 TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS Unitek Corp. JEX Class I 1992-11-25
K924739 THE DENTIST'S TOOTH POLISHER Ranir/Dcp Corp. JEQ Class I 1992-11-24
K921408 LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE Ultradent Products, Inc. EJK Class II 1992-11-24
K920508 BIO-OSS BLOCKS Geistlich-Pharma LYC Class II 1992-11-24
K924670 DENTIN RELIEF Professional Technologies Corp. KLE Class II 1992-11-23
K924295 DEBRACKETING INSTRUMENT Unitek Corp. JEX Class I 1992-11-23
K923979 LC TRAY MATERIAL Dentsply Intl. EBH Class I 1992-11-17
K924024 ORTHO WAX Heraeus Kulzer, Inc. EGD Class I 1992-11-17
K924241 ARGENCO 75M Argen Precious Metals, Inc. EJT Class II 1992-11-09
K921044 ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND Wallace A. Erickson & Co. DYH Class II 1992-11-09
K923674 DENSPRO COARSE MINT PROPHY PASTE Teledyne Getz EJR Class I 1992-11-05
K923675 DENSPRO MEDIUM MINT PROPHY PASTE Teledyne Getz EJR Class I 1992-11-05
K920905 BIOFORCE WIRE Gac Intl., Inc. DZC Class I 1992-11-04
K924526 DENTURE PLASTIC TEETH Austenal, Inc. ELM Class II 1992-11-04
K915865 AIT IMPLANT SYSTEM American Implant Technology, Inc. DZE Class II 1992-11-04
K924422 PALABOND Heraeus Kulzer, Inc. EBI Class II 1992-11-04
K921173 TYPE 1 DENTAL CEMENT Centrix, Inc. EMA Class II 1992-11-04
K922988 ECO/DENTAL GENERAL DENTAL PACK Dyna-Pace Systems, Inc. EKJ Class I 1992-11-04
K923644 DW243-64 Ivoclar USA, Inc. EJS Class II 1992-11-04
K921764 DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS Implant Support Systems, Inc. DZE Class II 1992-11-03
K923432 GERMAN MINI DYNALOCK Unitek Corp. EJF Class I 1992-10-30
K915848 SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. Sensor Medics Corp. DZJ Class II 1992-10-28
K923926 IPS CERAMIC ETCHING GEL Ivoclar North America, Inc. ELL Class II 1992-10-27
K923399 CHALLENGE II - PASTE ADHESIVE Ormco Corp. DYH Class II 1992-10-27
K921854 IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM Impla-Med DZE Class II 1992-10-27
K923802 TIMESH TITANIUM MINI-SOFTPLATE/SCREW Ti-Mesh, Inc. JEY Class II 1992-10-26
K923639 DIAMOND COATED DENTAL INSERTS Dentsply Intl. ELC Class II 1992-10-26
K924182 CALCIMOL LC Voco GmbH EJK Class II 1992-10-16
K924635 ALPHA-DENT PIT AND FISSURE SEALANT Wallace A. Erickson & Co. EBC Class II 1992-10-16
K923949 SYLVAN DENTAL HEADLIGHT SYSTEM Sylvan Medical Fiberoptics EBA Class I 1992-10-16
K924181 POLIBOND Voco GmbH KLE Class II 1992-10-16
K923839 NITINOL GENTLE TOUCH COIL SPRING Ultimate Wireforms, Inc. DZC Class I 1992-10-15
K913228 INTERPORE IMZ CYLINDER IMPLANT SYSTEM Interpore Intl. DZE Class II 1992-10-13
K923472 COMPACOLOR Wilde-USA, Inc. EBF Class II 1992-10-13
K923867 METAFIL Parkell EBF Class II 1992-10-06
K923974 SILIMAT PLUS Ivoclar North America, Inc. EFD Class I 1992-10-06
K923469 ORALSAFE Oralsafe, Inc. EFB Class I 1992-10-05
K923842 BISCO UNIVERSAL BOND-3 Bisco, Inc. KLE Class II 1992-09-29
K923549 PALADISC LC Heraeus Kulzer, Inc. EBH Class I 1992-09-29
K923586 BURNOUT MATERIAL Dentsply Intl. EGD Class I 1992-09-29
K923546 OPTIBOND Kerr Corporation (Danbury) KLE Class II 1992-09-29
K923849 CALCIMOL Voco GmbH EJK Class II 1992-09-28
K921599 ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN Ultradent Products, Inc. EBC Class II 1992-09-28
K921600 ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE Ultradent Products, Inc. EBC Class II 1992-09-28
K923029 ORTHODONTIC STAINLESS STEEL BRACKET Gac Intl., Inc. EJF Class I 1992-09-28
K921355 WINGMASTER Innovators, Inc. EHB Class I 1992-09-25
K921354 BLUNT TIP IRRIGATION NEEDLES Innovators, Inc. EKJ Class I 1992-09-25
K921771 MINIDAM II Delsan Dental Systems EIE Class I 1992-09-17
K915898 PALADUR Heraeus Kulzer, Inc. EBI Class II 1992-09-16
K923285 PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE Smith & Nephew, Inc. ECB Class I 1992-09-15
K922957 PARAGON Jeneric/Pentron, Inc. EJS Class II 1992-09-14
K922956 KB40-KF Jeneric/Pentron, Inc. EJS Class II 1992-09-14
K923236 TRIAD INLAY COMPOSITE Dentsply Intl. EBF Class II 1992-09-11
K921598 ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE Ultradent Products, Inc. EBF Class II 1992-09-09
K921602 ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT Ultradent Products, Inc. EBF Class II 1992-09-09
K923020 CLEANIC Hawe Neos Dental EJR Class I 1992-09-09
K921409 ENAMEL AND PORCELAIN ETCH PRODUCT LINE Ultradent Products, Inc. EBF Class II 1992-09-09
K923328 VENEER CEMENT Dentsply Intl. EMA Class II 1992-09-09
K921407 COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE Ultradent Products, Inc. EBF Class II 1992-09-09
K914892 SALIVA-STIM Orion Diagnostica, Inc. EGD Class I 1992-09-02
K920892 LITE FIL II A Shofu Dental Corp. EBF Class II 1992-09-01
K920893 LITE FILL II P Shofu Dental Corp. EBF Class II 1992-09-01
K921174 COMPOSITE RESIN CORE PASTE MATERIAL Centrix, Inc. EBF Class II 1992-09-01
K923457 SHOWERFLOSS Summit Marketing Group, Inc. EFS Class I 1992-09-01
K921010 STERN ERA ALIGNMENT CORRECTION IMPLANT ABUTMENT Apm Stern Gold DZE Class II 1992-09-01
K905434 ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 Nobelpharma USA, Inc. DZE Class II 1992-08-27
K913853 FISSURE SEALER Ortho Source EBC Class II 1992-08-27
K923124 GLENROE GOLDEN ORTHODONTIC BRACKET Glenroe EJF Class I 1992-08-27
K923202 Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL Jeneric/Pentron, Inc. ELW Class II 1992-08-27
K920850 GAC THUMB-SUCKING CONTROL APPLIANCE Gac Intl., Inc. DZC Class I 1992-08-24
K921604 TOUCH N' HEAT, MODIFICATION Analytic Technology EKZ Class II 1992-08-24

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