meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
65
Latest Decision
1985-08-16

Clearances · page 114 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852745 PORCELAIN VENEER SYSTEM BONDING KIT The S. S. White Co. EBF Class II 1985-08-16
K852981 PREFORMED TOOTH ARCH Swipes Dental Laboratory ELM Class II 1985-08-16
K853005 S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM The S. S. White Co. EGZ Class I 1985-08-13
K851136 TROPHY COMPACT - DENTAL UNIT Trophy Radiologie EIA Class I 1985-07-31
K852521 SATLEC PROPHY UNIT PU 3055 Spelna, Inc. KOJ Class II 1985-07-31
K852599 A-COMPANY ELASTOMERIC TUBING A Company, Inc. ECI Class I 1985-07-31
K852600 A-COMPANY ELASTOMERIC CHAIN DISPENSER A Company, Inc. ECI Class I 1985-07-31
K852596 A-COMPANY ELASTIC LIGATURE RINGS A Company, Inc. ECI Class I 1985-07-31
K851052 TUBULITEC PRIMER Dental Therapeutics AB LBH Class II 1985-07-31
K852597 A-COMPANY ELASTIC ROTATION WEDGES A Company, Inc. ECI Class I 1985-07-31
K852814 GLOSSY POLISHING PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1985-07-31
K852906 DURACLEAN DENTURE CLEANER Astron Dental Corp. JER Class I 1985-07-31
K852598 A-COMPANY SEPARATING ELASTICS A Company, Inc. ECI Class I 1985-07-31
K852670 A-COMPANY ESPREE SAFETY HEADGEAR A Company, Inc. DZB Class II 1985-07-31
K851073 CUPRIDENT Bio Systems, Inc. EJR Class I 1985-07-31
K852347 DENTAL CASTING ALLOY GDC 1686 Deringer-Ney, Inc. EJS Class II 1985-07-31
K851929 RESTORE* Johnson & Johnson Professionals, Inc. EBF Class II 1985-07-31
K852743 PORCELAIN VENEER SYSTEM LABORATORY KIT The S. S. White Co. EIH Class II 1985-07-31
K852476 INTERPLAK Dental Research Corp. JEQ Class I 1985-07-31
K852524 SATALEC SERVOTORQUE S2 SX2 Spelna, Inc. EIA Class I 1985-07-31
K852800 A-COMPANY SELF-LIGATING APPLIANCE A Company, Inc. EJF Class I 1985-07-31
K852756 TELEDYNE GETZ BARRIER-DENTIN SEALER Scientific Pharmaceuticals, Inc. LBH Class II 1985-07-31
K852659 BIOGLOSS Dentsply Intl. EBF Class II 1985-07-30
K852660 ETCH AND BOND Dentsply Intl. KLE Class II 1985-07-25
K851053 TUBULITEC LINER Dental Therapeutics AB EJK Class II 1985-07-25
K852593 SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 Northern Electric Co. Div. of Sunbeam Corp. EFS Class I 1985-07-24
K852658 ETEN-GEL Dentsply Intl. EBF Class II 1985-07-24
K852157 TEMREX DENTAL POLISHING PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1985-07-19
K851915 CURING LIGHT Technology, Inc. EBZ Class II 1985-07-09
K850084 TRINDIUM-DENTAL MATERIAL Trindium Corp. of America EJH Class II 1985-07-08
K850927 COMPLETE DENTURE REPAIR KIT Tooth Aid Lab, Inc. EBO Class II 1985-07-02
K851718 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES Artiberia EMK Class I 1985-07-02
K851903 ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN Astra Pharmaceutical Products, Inc. EJI Class II 1985-07-02
K851724 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS Artiberia EKB Class I 1985-07-02
K851727 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA Artiberia EIK Class I 1985-07-02
K852145 CAPA PRE-FORMED PORCELAIN CROWN Capa Industries ELL Class II 1985-07-02
K852182 EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER The S. S. White Co. EBH Class I 1985-07-02
K851722 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS Artiberia EKC Class I 1985-07-02
K851730 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST Artiberia EJY Class I 1985-07-02
K851720 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS Artiberia EGN Class I 1985-07-02
K851723 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS Artiberia EKD Class I 1985-07-02
K851726 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN Artiberia EIY Class I 1985-07-02
K851872 BLENGOLD SPECIAL Heraeus Dental Gold Corp. EJT Class II 1985-07-02
K851729 2620/1 TO 2635/2 VARIOUS DENTAL CROWN SCISSORS Artiberia EIR Class I 1985-07-02
K851721 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS Artiberia EMN Class I 1985-07-02
K852344 DISTALITE POSTERIA DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. EBF Class II 1985-07-01
K851708 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA Artiberia EMG Class I 1985-07-01
K852540 ULTRASONIC TOOTH SCALER MODEL DSCIOP Parkell, Inc. ELC Class II 1985-07-01
K852151 PHOTO CURING LIGHT Dentsply Intl. EBF Class II 1985-07-01
K851944 MAX-I-PROBE HANDPIECE Solo Pak Laboratories EIC Class I 1985-07-01
K852400 PLAK SMACKER Plak Smacker Toothbrush Co. EFW Class I 1985-07-01
K852279 SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 Northern Electric Co. Div. of Sunbeam Corp. JEQ Class I 1985-07-01
K852489 PROPOL DENTAL POLISHING PASTE Scientific Pharmaceuticals, Inc. EJR Class I 1985-07-01
K851030 TEMREX-DENTIN VARNISH Temrex Corp. LBH Class II 1985-06-20
K852196 ZIONOMER CEMENT Den-Mat Corp. EMA Class II 1985-06-20
K844480 DENTAL ORAL CARE SYSTEMS & COMPONENTS Advanced Bio Systems, Inc. EBO Class II 1985-06-19
K851717 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR Artiberia EMJ Class I 1985-06-14
K851715 830/4 TO 848/7 VARIOUS TYPES CHISELS Artiberia EML Class I 1985-06-11
K851712 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI Artiberia EMG Class I 1985-06-11
K851709 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN Artiberia EMG Class I 1985-06-11
K851714 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS Artiberia EMM Class I 1985-06-11
K851710 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC Artiberia EMH Class I 1985-06-11
K851713 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA Artiberia EMJ Class I 1985-06-11
K851716 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES Artiberia EMI Class I 1985-06-11
K851711 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE Artiberia EMG Class I 1985-06-11
K852019 BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD Belmont Equipment Corp. EAP Class II 1985-06-05
K851878 A COMPANY BRASS SEPARATING RINGS A Company, Inc. DZC Class I 1985-06-05
K851648 HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE Heraeus Dental Gold Corp. EJS Class II 1985-06-04
K850294 CANAL FINDER Roseburg SA EGS Class I 1985-06-04
K851569 VERA BOND NON PERCIOUS CERAMIC ALLOY Aalba Dent, Inc. EJH Class II 1985-05-29
K851388 SEPTOSIL SILICONE FOR PRECISION IMPRESSION Specialites Septodont ELW Class II 1985-05-29
K850666 STROBEX ULTRON ELECTROSURGE-DENTAL UNIT Ipco Corp. EKZ Class II 1985-05-29
K843539 TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- Molnlycke A/S Hospital Products EFN Class I 1985-05-23
K850650 DENTAL ACRYLIC POLYMERS Cole Polymers , Ltd. EBI Class II 1985-05-22
K851459 VISILUX 2 VISIBLE LIGHT CURING UNIT 3M Company EBF Class II 1985-05-21
K851006 T-SWIPE -TONGUE CLEANER Kumar Ent. LCN Class I 1985-05-21
K851367 HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION Orthomatrix, Inc. DZE Class II 1985-05-21
K842720 BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL Penn-Med Technology, Inc. EJL Class I 1985-05-21
K851105 TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ The Huxley Instrument Corp. EMG Class I 1985-05-15
K850610 PEPSODENT DENTURE ADHESIVE CREAM Lever Brothers Company, Inc. EBD Class II 1985-05-15
K851055 SENTINOL -ORTHODONTIC ARCH WIRE Gac Intl., Inc. DZC Class I 1985-05-09
K851468 76 EMA LINING CEMENT G-C Intl. Corp. EMA Class II 1985-05-01
K851469 76 ELW BITE CHECKER SILICONE G-C Intl. Corp. ELW Class II 1985-05-01
K851182 PEPSODENT DENTURE CLEANSER-WESTONE FORMULA Lever Brothers Company, Inc. EFT Class I 1985-04-29
K851386 UNITEK DISPOSABLE IMPRESSION SYRINGE Unitek Corp. EID Class I 1985-04-29
K851183 PEPSODENT DENTURE CLEANSER PDP FORMULA Lever Brothers Company, Inc. EFT Class I 1985-04-29
K851454 A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS A Company, Inc. ECQ Class I 1985-04-29
K851038 ARCEE DENTAL POST Arcee Dental Products Co. ELR Class I 1985-04-29
K851045 DENT-DR. VACU-FRAME Dent-Dr. EIE Class I 1985-04-22
K851056 OPAQUER/BONDING AGENT Dentsply Intl. KLE Class II 1985-04-22
K850965 KULZER DENTIN ADHESIVE Kulzer, Inc. EBF Class II 1985-04-22
K850012 ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO Heyltex Corp. LYC Class II 1985-04-22
K850863 ULTRAFIL-LT (GUTTA PERCHA) The Hygenic Corp. EKM Class I 1985-04-16
K850911 TRIAD C & B MATERIAL Dentsply Intl. EBF Class II 1985-04-16
K850988 BOVO MOISTURE GUARD E.H. Medical Co. KHR Class I 1985-04-16
K850915 WAX BITE IMPRESSION WAFER Toothprints, Inc. EGD Class I 1985-04-16
K850906 TACTILE PLUS DENTAL ELEVATORS Ipco Corp. EMJ Class I 1985-04-12
K850706 F-SERIES IMPLANT Omni Intl., Inc. DZE Class II 1985-04-10
K850775 DENTAL MASSAGING PICKS L.A.K. Ent., Inc. JET Class I 1985-04-10
K850913 GLAS IONOMER CEMENT Shofu Dental Corp. EMA Class II 1985-04-10

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