meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1990-03-14

Clearances · page 103 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K897020 ALL-BOND DENTIN BONDING SYSTEM Bisco, Inc. KLE Class II 1990-03-14
K896621 L.T.C. REPLACEMENT GASTROSTOMY TUBE Intl. Medical Marketing, Inc. KCQ Class I 1990-03-13
K896950 CORE BUILD UP COMPOSITE Confi-Dental Products Co. EBF Class II 1990-03-13
K896878 HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) Micro Motors, Inc. EFB Class I 1990-03-08
K896913 SPIRIT Ormco Corp. DYW Class II 1990-03-08
K896876 DYNATORQ DENTAL HANDPIECE ATTACHMENTS Micro Motors, Inc. EFB Class I 1990-03-07
K895345 ORAD TOOTHBRUSH CLEANER Orad, Inc. EFT Class I 1990-03-07
K896877 DENTAL AIR MOTORS (SEVERAL MODELS) Micro Motors, Inc. EFB Class I 1990-03-07
K895988 POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL Milton Hodosh, M.D. EMA Class II 1990-03-07
K896879 ORAL SURGERY HANDPIECE AND ATTACHMENTS Micro Motors, Inc. EFB Class I 1990-03-07
K896843 EXPLORER 24 DENTAL HAND INSTRUMENT American Medical Ceramics, Inc. EKJ Class I 1990-03-06
K896928 FILPOST Ivoclar North America, Inc. ELR Class I 1990-03-05
K895269 DEN-MAT LAMI-QUICK Den-Mat Corp. ELL Class II 1990-02-22
K896719 PRIMER-P ADHESIVE AGENT Parkell EBI Class II 1990-02-22
K896649 GRANITEC Z2, ZINC PHOSPHATE CEMENT Confi-Dental Products Co. EMA Class II 1990-02-22
K896655 9.6% HYDROFLUORIC ACID GEL Pulpdent Corp. KLE Class II 1990-02-14
K896663 ENDO-PREP Pulpdent Corp. EKM Class I 1990-02-14
K896602 FD5000 DENTAL CHAIR Oriola OY Finndent KLC Class I 1990-02-14
K896890 DYNASURG DENTAL IRRIGATION SYSTEM Micro Motors, Inc. EFS Class I 1990-02-14
K896653 SEPARATING MEDIUM (POLYVINYL ALCOHOL) Pulpdent Corp. EBF Class II 1990-02-14
K895283 PROSTHETIC RESTORATION DEVICE Swiss Precision Mfg. Corp. EBL Class I 1990-02-14
K895066 MONOGRAM IV Leach and Dillon Co., Inc. EJT Class II 1990-02-14
K896657 ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA Pulpdent Corp. KIF Class II 1990-02-14
K896661 KEN'S PROPHY GEL - REGULAR Pulpdent Corp. EJR Class I 1990-02-14
K896656 ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH Pulpdent Corp. KIF Class II 1990-02-14
K896658 DENTIN DISCLOSING GEL AND GEL REMOVER Pulpdent Corp. EBF Class II 1990-02-14
K893736 HOT BRUSH Home Dental Care, Inc. JEQ Class I 1990-02-14
K896659 SILANE Pulpdent Corp. KLE Class II 1990-02-14
K896693 FLEXI-CAST CROWN CORE SYSTEM Essential Dental Systems, Inc. ELR Class I 1990-02-14
K896654 DRYING AGENT Pulpdent Corp. EBF Class II 1990-02-14
K896662 AIR BLOCK Pulpdent Corp. EBF Class II 1990-02-14
K894595 BONEFIT R SCREW IMPLANTS Institut Straumann AG DZE Class II 1990-02-13
K894594 BONEFIT HOLLOW SCREW IMPLANTS Institut Straumann AG DZE Class II 1990-02-13
K894593 BONEFIT HOLLOW CYLINDER IMPLANTS Institut Straumann AG DZE Class II 1990-02-13
K896532 DENTAL DELIVERY SYSTEM Dentech Corp. EIA Class I 1990-02-12
K896501 TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS) Leach and Dillon Co., Inc. EJH Class II 1990-02-09
K896821 OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE North American Sterilization & Packaging Co. KOQ Class I 1990-02-09
K896539 PERMADYNE GARANT LOW VISCOSITY Espe GmbH (Us) ELW Class II 1990-02-09
K896470 EOS IMPRESSION TRAYS Ivoclar North America, Inc. EHY Class I 1990-02-09
K895189 ADJUSTABLE SOFT PALATE LIFTER Ortho Publications, Inc. LRK Class II 1990-02-09
K900401 NAS&P GRASPING FORCEPS & ASSOC. DEVICES North American Sterilization & Packaging Co. KOQ Class I 1990-02-09
K896564 DENTAL CORE MATERIAL Dentsply Intl. EBF Class II 1990-02-09
K894953 GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS Confi-Dental Products Co. EMA Class II 1990-02-06
K894844 BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS Straumann Institute, Ltd. DZE Class II 1990-02-02
K896565 DMV(R) VENEER SUCTION GRIPPER Dmv Corp. EKJ Class I 1990-02-02
K896361 HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE Dentalez Group EFB Class I 1990-02-02
K896348 ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL. Argen Precious Metals, Inc. EJT Class II 1990-02-01
K896382 MODIFIED GLUMA BONDING SYSTEM Heraeus Kulzer, Inc. KLE Class II 1990-02-01
K896337 DENTAL BRIDGE ANCHORING PINS Gayso Bridge-Tech, Inc. EGG Class I 1990-01-31
K895483 ACME COATED ORTHODONTIC ARCHWIRE Acme-Monaco Corp. EJF Class I 1990-01-29
K896249 BANDTITE GLASS IONOMER CEMENT American Orthodontics EMA Class II 1990-01-26
K896219 SAFE-T-CAP NEEDLE COVER Ausmedics Pty , Ltd. DZM Class I 1990-01-22
K896024 MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE Mdt Diagnostic Co. EAP Class II 1990-01-22
K896963 TRIMODE SP DENTAL INTRA ORAL X-RAY Tempo Technology, Inc. EAP Class II 1990-01-22
K896149 ANEST-EZE DENTAL DRILL RA#2 Signature One Products, Inc. DZA Class I 1990-01-19
K896529 BASIC CALCIUM HYDROXIDE LINER Ivoclar North America, Inc. EJK Class II 1990-01-16
K895985 SANI-PIKS DENTAL HAND INSTRUMENT Bison-Lee Co. EKJ Class I 1990-01-10
K896132 ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) Ivoclar North America, Inc. EBF Class II 1990-01-10
K894092 DENTAL ENDODONTIC CEMENT (MODIFICATION) The Hygenic Corp. KIF Class II 1990-01-10
K894477 INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM Cosmedent, Inc. EMA Class II 1990-01-10
K896586 RATE INCREASE FOR IPPB/IPV Percussionaire Corp. DZD Class I 1990-01-09
K895877 RAMCLEAN DENTAL VACUUM LINE CLEANER Ramvac Corp. EIA Class I 1989-12-26
K895876 RAMVAC DENTAL VACUUM SYSTEM Ramvac Corp. EIA Class I 1989-12-26
K894282 FIRST IMPRESSION TM Coe Laboratories, Inc. ELW Class II 1989-12-22
K895976 TOOTH SHADE RESIN G-C Intl. Corp. EBF Class II 1989-12-22
K895750 HEMA-PRIMER Parkell KLE Class II 1989-12-21
K891346 ARTECH TYPE SS SUBMERGED SCREW IMPLANT Artech Corp. DZE Class II 1989-12-21
K894058 ISODENT Eurodent, Inc. EIA Class I 1989-12-21
K895714 ORTHO-KEV APPLIANCE REINFORCING SYSTEM American Orthodontics EBI Class II 1989-12-21
K895798 SILCOT COPAL CAVITY VARNISH Specialites Septodont EMA Class II 1989-12-21
K895758 PLASTIC TOOTH REINFORCEMENT KIT Nanzee Dental Products EBL Class I 1989-12-20
K894085 TALLADIUM TILITE CERAMIC ALLOY Talladium, Inc. EJH Class II 1989-12-20
K893800 SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL) Deringer-Ney, Inc. EJT Class II 1989-12-20
K895056 LOW FUSING WHITE GOLD Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895060 750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895070 SELECT WHITE Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895054 .650 FINE GOLD SOLDER Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895067 SELECT 60 Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895063 450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895069 SELECT 40 Leach and Dillon Co., Inc. EJT Class II 1989-12-19
K895062 500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895055 .730 FINE GOLD SOLDER Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895049 200 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895736 LYNX-HIGH SPEED HANDPIECE Mti Precision Products EFB Class I 1989-12-18
K895064 MONOGRAM II Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895068 SELECT 50 Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895052 .585 FINE GOLD SOLDER Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895061 700 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895050 100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895065 MONOGRAM III Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895742 LITELINE VLC SOFT RELINE Dentsply Intl. EBI Class II 1989-12-18
K895051 MONOGRAM I Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895057 HIGH FUSING WHITE GOLD Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895048 300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895053 .615 FINE GOLD SOLDER Leach and Dillon Co., Inc. EJT Class II 1989-12-18
K895508 CALASEPT PASTE Js Dental Mfg., Inc. EJK Class II 1989-12-08
K895523 PHASE II ORTHODONTIC ADHESIVE Reliance Orthodontic Products, Inc. DYH Class II 1989-12-08
K895522 LIGHT BOND PASTE W/FLUORIDE Reliance Orthodontic Products, Inc. DYH Class II 1989-12-07
K895521 RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) Reliance Orthodontic Products, Inc. DYH Class II 1989-12-07
K895401 NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM Rocky Mountain Orthodontics, Inc. EBF Class II 1989-12-04

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