meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
45
Latest Decision
1993-09-13

Clearances · page 92 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932227 AMELOGEN RESTORATIVE MATERIALS Ultradent Products, Inc. EBF Class II 1993-09-13
K932793 PULPDENT 2.5% NITRIC ACID ETCHANT Pulpdent Corp. EBF Class II 1993-09-13
K920452 THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST Nobelpharma USA, Inc. DZE Class II 1993-09-13
K923218 NITANIUM PALATAL EXPANDER Ortho Organizers, Inc. EJF Class I 1993-09-13
K925064 RELAX-O-GUARD Aquatemp Service Co., Inc. KMY Class I 1993-09-13
K932025 ION-IMPLANTED NEO SENTALLOY Gac Intl., Inc. EJF Class I 1993-09-13
K925012 PLASTIC CHAIN American Orthodontics EJF Class I 1993-09-13
K921571 1ST IMPRESSION Wykle Research, Inc. ELW Class II 1993-09-10
K922942 PRO-SCOPE MODEL # PS-4000 Pro-Den Systems, Inc. EIA Class I 1993-09-10
K931867 ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE Ultradent Products, Inc. EBF Class II 1993-09-09
K932792 PULPDENT MALEIC ACID ETCHANTS Pulpdent Corp. EBF Class II 1993-09-09
K930337 PROFAST(R)-DENTURE CLEANSER Fittydent-Altwirth & Schmitt GmbH EFT Class I 1993-09-07
K931980 STAINLESS STEEL ORTHODONTIC PRODUCTS Ortho Organizers, Inc. DYO Class I 1993-09-01
K932395 VLC DR MATERIAL Dentsply Intl. EBF Class II 1993-08-25
K931710 PULPDENT DENTAL BOND ENHANCER 2-B Pulpdent Corp. KLE Class II 1993-08-24
K930405 BISCO D/C CORE COMPOSITE Bisco, Inc. EBF Class II 1993-08-24
K932920 GLENROE PLASTIC BRACKET Glenroe Technologies DYW Class II 1993-08-24
K925967 MEDCAM Medcam USA, Inc. EIA Class I 1993-08-24
K932459 FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL 3M Company ELW Class II 1993-08-09
K932034 PALAVIT 55 AND DENTACOLOR CONNECTOR Heraeus Kulzer, Inc. EBG Class II 1993-08-06
K925313 TITANIUM COC ABUTMENT HEADS FOR IMZ Implant Support Systems, Inc. DZE Class II 1993-07-30
K930178 ELECTRO FLOSS Arizona Implant Dentistry JET Class I 1993-07-28
K931631 COATED ORTHODONTIC DEVICES Wonder Wire DZC Class I 1993-07-28
K914724 ADA SHANK EXTENSION Implant Corp. of America DZA Class I 1993-07-27
K931353 FLOSS PLUS Floss Plus, Inc. JES Class I 1993-07-27
K923883 DENTAL OR SURGICAL BUR Stratum Dental Technologies, Inc. EJL Class I 1993-07-27
K925349 ONE SYSTEM TAPERED TITANIUM ABUTMENTS Implant Support Systems, Inc. NHA Class II 1993-07-27
K932675 GXP DENTAL X-RAY PROCESSOR Gendex Corp. EGN Class I 1993-07-26
K932002 BARITONE C2, MODIFICATION Confi-Dental Products Co. EBC Class II 1993-07-22
K932379 ALL-BOND(R) JR. Bisco, Inc. KLE Class II 1993-07-22
K925375 CONSEPSIS SCRUB Ultradent Products, Inc. LBH Class II 1993-07-22
K923157 DENTAL RUBBER DAM Aseptico, Inc. EIE Class I 1993-07-22
K925739 HIGH SPEED DENTAL DRILL/HANDPIECE Feather Touch, Inc. EFB Class I 1993-07-22
K922805 NOBELPHARMA TORQUE CONTROLLER Nobelpharma USA, Inc. DZE Class II 1993-07-22
K931309 VARIOLINK Ivoclar North America, Inc. EBF Class II 1993-07-22
K911592 STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT Steri-Oss, Inc. DZE Class II 1993-07-22
K931869 ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE Ultradent Products, Inc. EBC Class II 1993-07-22
K931462 GLENROE CHAIN Glenroe Technologies, Inc. ECI Class I 1993-07-22
K931870 BONDING RESIN PRODUCT LINE Ultradent Products, Inc. KLE Class II 1993-07-22
K931857 SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT Confi-Dental Products Co. EBC Class II 1993-07-22
K931868 PRIMADRY PRODUCT LINE Ultradent Products, Inc. EBC Class II 1993-07-22
K922954 R1, R2, AND R1+ Jeneric/Pentron, Inc. EJH Class II 1993-07-22
K931502 VIVAGLASS LINER Ivoclar North America, Inc. EJK Class II 1993-07-22
K925378 STERI-SOL SOLUTION, MODIFICATION Anodia Systems EFB Class I 1993-07-22
K930698 THE MODEL 3003 SCALER Dentsply Intl. ELC Class II 1993-07-22
K931352 PEDO JACKETS OR PJ'S George M. Wilson, Dds ELZ Class I 1993-07-21
K931725 ALPHA II Dynarad Corp. EHD Class II 1993-07-14
K931554 ARGELITE 85 Argen Precious Metals, Inc. EJT Class II 1993-07-14
K930925 INTREX INTERORAL DENTAL X-RAY UNIT Keystone X-Ray, Inc. EAP Class II 1993-07-13
K931360 ELECTRIC TOOTH-BRUSH U.S. Dentek Corp. JEQ Class I 1993-07-13
K931475 ARGELITE 55 Argen Precious Metals, Inc. EJT Class II 1993-07-08
K932130 FREEDOM PLUS (CODE NAME MISC-LIB-013) J.F. Jelenko & Co., Inc. EJT Class II 1993-07-08
K924975 THE ORTHOTRAINER Myofunctional Research Corp. Pty. , Ltd. KMY Class I 1993-07-08
K932039 G-CERA ORBIT COLOUR COMMUNICATION SET GC America, Inc. EIH Class II 1993-07-08
K931812 NEW DENTINE ADHESIVE Dentsply Intl. KLE Class II 1993-07-08
K926382 THERASNORE Dr. Thomas E. Meade LRK Class II 1993-07-08
K930452 SOLO TIES Zulaf, Inc. EJF Class I 1993-07-08
K924132 E.Z. TEMEP, TEMPORARY FILLING MATERIAL Cosmedent, Inc. EMA Class II 1993-07-08
K925359 RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS Confi-Dental Products Co. DYH Class II 1993-07-08
K931838 DENTHESIVE II Heraeus Kulzer, Inc. KLE Class II 1993-07-08
K932013 CHARISMA -- MODIFIED Heraeus Kulzer, Inc. EBF Class II 1993-07-08
K931229 VARIGLASS VLC GLASS IONOMER Dentsply Intl. EMA Class II 1993-07-08
K931663 NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL Ortho Organizers, Inc. EJF Class I 1993-07-08
K924982 CONSEPSIS(TM) Ultradent Products, Inc. LBH Class II 1993-07-08
K931204 AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) Den-Tal-Ez Mfg Co., Inc. EIA Class I 1993-07-08
K921893 COLGATE ODONTOSON ULTRASONIC SCALER Perio-Giene ELC Class II 1993-07-08
K931880 PROFILL LC COMPOSITE Jedental Co., Inc. EBF Class II 1993-07-08
K925207 GLASS IONOMER CEMENT Milton Hodosh, M.D. EMA Class II 1993-07-08
K915634 FRESENIUS PD+ EXCHANGE DEVICE Fresenius USA, Inc. EKX Class I 1993-07-01
K923902 STERILE DENTAL KITS Professional Sterile Systems, Inc. EKJ Class I 1993-06-29
K923999 ALASTIK NS Unitek Corp. ECI Class I 1993-06-24
K913582 COMPATIT R Wilde-USA, Inc. ELM Class II 1993-06-24
K924974 THE TMJ APPLIANCE Myofunctional Research Corp. Pty. , Ltd. KMY Class I 1993-06-23
K931365 DW207 #28G, DW207 #35F, DW207 #39LC Ivoclar North America, Inc. EJT Class II 1993-06-22
K930487 PALATRAY LC MINT Heraeus Kulzer, Inc. EBH Class I 1993-06-18
K925240 FACEBOW Forestadent Bernhard Forster GmbH DZB Class II 1993-06-18
K925027 PHOTAC-FIL APLICAP Espe GmbH (Us) EMA Class II 1993-06-18
K930614 ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST Wallace A. Erickson & Co. DYH Class II 1993-06-17
K930116 LCL 8 Voco GmbH EMA Class II 1993-06-17
K924727 100 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBF Class II 1993-06-17
K931742 INJECT-R FILL Union Broach, Div. Moyco Industries, Inc. EKM Class I 1993-05-27
K926147 GOLD-PLATINUM BASED CASTING ALLOY Jeneric/Pentron, Inc. EJS Class II 1993-05-27
K926347 DUCERANIUM U Degussa AG EJH Class II 1993-05-27
K930504 NEW DENTIN PRIMER Dentsply Intl. KLE Class II 1993-05-27
K931096 DURAFLOR Pharmascience, Inc. LBH Class II 1993-05-27
K931084 TEMPIT Centrix, Inc. EMA Class II 1993-05-27
K926146 BIO C & B Jeneric/Pentron, Inc. EJS Class II 1993-05-27
K924190 ISS O-RING ATTACHMENT Implant Support Systems, Inc. DZE Class II 1993-05-27
K925163 MICODOSE CHLORHEXIPREP Unicep ECM Class I 1993-05-27
K924971 FORESTADENT BRACKETS Forestadent Bernhard Forster GmbH EJF Class I 1993-05-27
K930202 TITAN SEPARATING SPRING Ortho Spectrum, Inc. DZC Class I 1993-05-27
K922985 CLEAN UP Bio-Probe, Inc. EIA Class I 1993-05-27
K930453 SINGLES Nexadental ECI Class I 1993-05-27
K925331 CORRECT AND CORRECT FIT II Jeneric/Pentron, Inc. EJS Class II 1993-05-27
K931162 KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH King Dental Corp. ELM Class II 1993-05-27
K923980 Q3 DISPOSABLE PROPHY ANGLE Q3 Special Products, Inc. EGS Class I 1993-05-27
K930764 ENDO-ICE-PULP TESTER-THERMAL The Hygenic Corp. EAT Class II 1993-05-27
K930761 IMAGE-X 70 INTRAORAL X-RAY SYSTEM Afp Imaging Corp. EAP Class II 1993-05-25
K931090 PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY Vident EJT Class II 1993-05-25
K931089 VGA-50 GOLD ALLOY Vident EJT Class II 1993-05-25

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