meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
39
Latest Decision
1990-06-06

Clearances · page 102 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K901236 RUBBER, DENTAL DAM (NON-STERILE) Naturub Sdn. Bhd. EIE Class I 1990-06-06
K901973 CP-3 DENTAL POLISHING MATERIAL Gresco Products, Inc. EJR Class I 1990-06-01
K901911 VIVAALLOY HR (AMALGAM) Ivoclar North America, Inc. EJJ Class II 1990-06-01
K900488 MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE American Orthodontics EJF Class I 1990-06-01
K900178 ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES Core-Vent Corp. EFS Class I 1990-05-31
K897195 A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) A Company, Inc. EKS Class I 1990-05-31
K901098 SPARTAN PLUS Ivoclar North America, Inc. EJT Class II 1990-05-29
K901077 PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) Scientific Pharmaceuticals, Inc. EBG Class II 1990-05-29
K901049 COPAL VARNISH Pulpdent Corp. LBH Class II 1990-05-29
K896469 EOS INLAY MATERIAL Ivoclar North America, Inc. EBF Class II 1990-05-25
K900946 UNIVERSUM Scientific Pharmaceuticals, Inc. LBH Class II 1990-05-25
K900681 PANORAMIC MODEL X-CALIBER X-RAY Belmont Equipment Corp. EAP Class II 1990-05-23
K900824 FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) Midwest Orthodontic Mfg. EJF Class I 1990-05-22
K901408 THE TONGUE BRUSH Garry Laboratories, Inc. LCN Class I 1990-05-21
K896340 BIOMER(R) F COMPOSITE LUTING CEMENT Dentsply Intl. EMA Class II 1990-05-15
K900991 SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET Tocad America, Inc. EFS Class I 1990-05-15
K900766 EPI DENT TOOTHBRUSH Epi Mfg. JEQ Class I 1990-05-15
K897009 PALFIQUE LIGHT BONDING AGENT Tokuyama America, Inc. KLE Class II 1990-05-15
K901239 TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE Teledyne Getz EFB Class I 1990-05-15
K900799 COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS Comfort Acrylics Co. EBI Class II 1990-05-15
K896481 PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER Purebrush Assoc. MCF Class I 1990-05-15
K896769 INTERFACE BONDING SYSTEM Smile Horizons, Inc. EBF Class II 1990-05-15
K896980 PALFIQUE LIGHT LINER Tokuyama America, Inc. EBI Class II 1990-05-15
K897010 PALFIQUE LIGHT COMPOSITE RESIN Tokuyama America, Inc. EBF Class II 1990-05-15
K900301 NOVUS BONDING AGENT The Hygenic Corp. EBI Class II 1990-05-15
K901488 LYNX-SM, SCLAER DENTAL HANDPIECE Mti Precision Products ELC Class II 1990-05-15
K897011 PALFIQUE LIGHT-S COMPOSITE RESIN Tokuyama America, Inc. EBF Class II 1990-05-15
K896981 TOKUSO REBASE Tokuyama America, Inc. EBI Class II 1990-05-15
K901396 CONCEPT INLAY/ONLAY Ivoclar North America, Inc. EBF Class II 1990-05-15
K901053 MIRROR SHIELD Pulpdent Corp. EKJ Class I 1990-05-07
K900135 CU-75 VISIBLE LIGHT-CURING UNIT Kab Gloves Unltd. EBZ Class II 1990-05-07
K900342 UNITY DENTAL CEMENT Whaledent Intl. Div. Ipco EMA Class II 1990-05-07
K896530 FERMIT TEMPORARY MATERIAL Ivoclar North America, Inc. EBF Class II 1990-05-07
K901532 GDC 3084 CASTING ALLOY Deringer-Ney, Inc. EJT Class II 1990-05-02
K901533 GDC 588 CASTING ALLOY The J.M. Co. EJT Class II 1990-05-02
K896468 EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL Ivoclar North America, Inc. ELW Class II 1990-04-30
K896915 PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL Jelenko Co. EJT Class II 1990-04-30
K901051 22% POLYACRYLIC ACID GEL Pulpdent Corp. EBF Class II 1990-04-30
K901094 HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY Grimm & Norton JEY Class II 1990-04-27
K901095 BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY Grimm & Norton JEY Class II 1990-04-27
K900061 IMPLA-MED TITANIUM, IMPLANT DEVICES Impla-Med DZE Class II 1990-04-27
K901178 AMALGAM CONDENSER American Medical Ceramics, Inc. EKJ Class I 1990-04-27
K901256 AMALCAP PLUS Ivoclar North America, Inc. EJJ Class II 1990-04-27
K901099 PROTOCOL (ALLOY) Ivoclar North America, Inc. EJS Class II 1990-04-25
K901097 FILLOCK REAMER Ivoclar North America, Inc. DZA Class I 1990-04-25
K901024 STAINLESS STEEL DENTAL WIRES AND CLASPS Ivoclar North America, Inc. EJF Class I 1990-04-25
K901257 WIRONTOM CLASP WIRE Ivoclar North America, Inc. EJW Class I 1990-04-25
K894935 S-70 PORTABLE DENTAL X-RAY SYSTEM Lorad Medical Systems, Inc. EHD Class II 1990-04-25
K896341 FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE Dentsply Intl. EBC Class II 1990-04-23
K896786 ZONAREX FINAL IMPRESSION COMPOUND Craft Dental Laboratory, Inc. ELW Class II 1990-04-19
K901050 NO-STICK COMPOSITE INSTRUMENT DIP Pulpdent Corp. EBD Class II 1990-04-19
K900275 OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET Collagen Corp. DZE Class II 1990-04-19
K896785 ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ Craft Dental Laboratory, Inc. ELW Class II 1990-04-19
K885159 MENSOR MAGNASKIRT Merrill C. Mensor, Jr., D.D.S. DZE Class II 1990-04-19
K900709 AIR FLOW SII Electro Medical Systems (Ems Sa) ELC Class II 1990-04-18
K901175 HAND MIRROR American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K900785 MICRO 2 SYSTEM Inodent EGG Class I 1990-04-16
K896139 SR-IVOSEAL Ivoclar North America, Inc. EBI Class II 1990-04-16
K896404 TITAMED ANTWERP SYSTEM Optik JEY Class II 1990-04-16
K901176 #23 EXPLORER American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901170 PERIODONTAL KNIFE American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901177 DISCOID/CLEOID DOUBLE END AMALGAM CARVER American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901169 5 STRAIGHT SCISSORS American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K896130 SR-IVOCAP Ivoclar North America, Inc. EBI Class II 1990-04-16
K901172 GRACEY CURETTE #13-14 American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901173 DISCOID SPOON EXCAVATOR American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901174 ELEVATOR #11 American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K900844 WEDJETS The Hygenic Corp. EIE Class I 1990-04-16
K901171 U-15 SINGLE END SCALER American Medical Ceramics, Inc. EKJ Class I 1990-04-16
K901052 PULPDENT OIL FREE SURFACE PREPARATION PASTE Pulpdent Corp. EJR Class I 1990-04-16
K895386 GLASION Scientific Pharmaceuticals, Inc. EMA Class II 1990-04-16
K900393 OPAQUE PORCELAIN Dentsply Intl. EIH Class II 1990-04-16
K895174 UNION BROACH BLEACHING LIGHT Union Broach, Div. Moyco Industries, Inc. EEG Class I 1990-04-13
K900690 CLEARFIL VENEER BOND KIT Kuraray Co. EBF Class II 1990-04-13
K900303 CONNECT Parkell EMA Class II 1990-04-12
K900507 DISPOSABLE SCREW TYPE PROPHY BRUSH Dentsply Intl. EHK Class I 1990-04-10
K895888 SILHOUETTE PORCELAIN Leach and Dillon Co., Inc. EIH Class II 1990-04-10
K900558 PERTAC BOND Espe GmbH (Us) KLE Class II 1990-04-10
K900578 SPORTS PACK ELASTICS Lancer Orthodontics, Inc. EJF Class I 1990-04-10
K895267 ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT Artech Corp. DZE Class II 1990-04-10
K900209 WILLI GELLER CERAMIC CREATION & SURPRISE Creation North America, Inc. EIH Class II 1990-04-09
K895854 ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) Acme-Monaco Corp. EJF Class I 1990-04-09
K900093 DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER Dentsply Intl. EFB Class I 1990-04-06
K895462 OSSEODENT DENTAL ATTACHMENTS Collagen Corp. DZE Class II 1990-04-04
K900631 SALIVA ABSORBER - DENTAL Kab Gloves Unltd. DYN Class I 1990-04-04
K895889 SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN) Leach and Dillon Co., Inc. EIH Class II 1990-04-04
K895818 STEADFAST DENTURE ADHESIVE CREAM Stiefel Research Institute, Inc. KOT Class I 1990-04-03
K900089 FG DIAMOND BURRS Kab Gloves Unltd. DZP Class I 1990-04-03
K900068 ARISTEE (RESIN, CROWN AND BRIDGES) Prometex, Inc. EBG Class II 1990-04-03
K900184 LINGUAL SHEATH Ormco Corp. EJF Class I 1990-04-02
K895085 WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT Lustgarten Multi-Tech International, Inc. EBZ Class II 1990-04-02
K895487 TEMPORARY DENTAL CEMENT Dentsply Intl. EMA Class II 1990-04-02
K900117 STELLITE COBALT/CHROMIUM BASE METAL ALLOY D.C. Dental Specialties EJH Class II 1990-04-02
K895463 OSSEODENT(R) PRECISION DENTAL ATTACHMENTS Collagen Corp. DZE Class II 1990-03-28
K896245 PLAK TRAC POWERED TOOTHBRUSH Windmere Corp. JEQ Class I 1990-03-28
K900436 PROTEMP II Espe GmbH (Us) EBG Class II 1990-03-28
K897130 INTERFACE - CAVITY LINER Scientific Pharmaceuticals, Inc. EJK Class II 1990-03-27
K897188 KETAC-CEM MAXICAP Espe GmbH (Us) EMA Class II 1990-03-27
K897101 DISPOSABLE PROPHY ANGLE AND ACCESSORIES Dentsply Intl. EFB Class I 1990-03-14
K897027 TEETHMATE-A Kuraray Co. EBC Class II 1990-03-14

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