meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
1995-04-14

Clearances · page 85 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931615 NITE-GUIDE ORTHO-TAIN, Inc. KMY Class I 1995-04-14
K943681 STERI-OSS SCALER FOR DENTAL IMPLANTS Steri-Oss, Inc. DZE Class II 1995-04-14
K945398 BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE Nobelpharma USA, Inc. DZE Class II 1995-04-13
K951237 ALGI-BAND Health-Dent Intl., Inc. ELW Class II 1995-04-10
K950905 C&B-METABOND RADIOPAQUE POWDER Parkell, Inc. KLE Class II 1995-04-10
K943186 CAPSET CALCIUM SULFATE BONE GRAFT PLASTER Lifecore Biomedical, Inc. LYC Class II 1995-04-10
K950667 AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER Chicago X-Ray Systems, Inc. EAP Class II 1995-04-06
K950256 TURBO 25/30 Parkell, Inc. ELC Class II 1995-04-04
K950240 LE CLEAN MACHINE Parkell, Inc. ELC Class II 1995-04-04
K951075 S & C VINYL POLYSILOXANE IMPRESSION MATERIAL S & C Polymer GmbH ELW Class II 1995-03-31
K950773 PROPHYLAXIS PACK Transidyne General Corp. EGS Class I 1995-03-31
K951111 RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) Lifecore Biomedical, Inc. DZE Class II 1995-03-31
K950743 ORAL PROCEDURE PACK Transidyne General Corp. EGS Class I 1995-03-31
K935676 MICRO RSH HIGH SPEED HANDPIECE Micro Motors, Inc. EFB Class I 1995-03-31
K945370 C-POST Bisco, Inc. ELR Class I 1995-03-31
K950894 SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) Argen Precious Metals, Inc. EJH Class II 1995-03-31
K944158 STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT Steri-Oss, Inc. DZE Class II 1995-03-29
K932866 RESOLUT REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. LYC Class II 1995-03-28
K950165 INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS Interpore Intl. LYC Class II 1995-03-28
K950187 FUTURA ONE Degussa Corp. EJT Class II 1995-03-24
K943720 ITI TRANSVERSAL SCREWING SYSTEM The Straumann Co. DZE Class II 1995-03-24
K950045 KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM Karl Leibinger GmbH U. Co. KG JEY Class II 1995-03-23
K950951 NEOCAST C, V, S Neodontics, Inc. EJH Class II 1995-03-23
K950517 HARMONY LINE PF Ivoclar North America, Inc. EJT Class II 1995-03-23
K950213 THE STERN ROOT ANCHOR SYSTEM Sterngold/Implamed ELR Class I 1995-03-23
K950991 DYRACT II RESTORATIVE Dentsply Intl. EBF Class II 1995-03-23
K950860 PERMALUTE Ultradent Products, Inc. KLE Class II 1995-03-23
K950859 PERMASEAL Ultradent Products, Inc. EBF Class II 1995-03-23
K923780 DENTOOL Dentool, Inc. EFB Class I 1995-03-21
K942698 VACSTAR Air Techniques, Inc. EIA Class I 1995-03-17
K950858 AUROLITE 55 Argen Precious Metals, Inc. EJT Class II 1995-03-16
K943204 VISTACAM Air Techniques, Inc. EIA Class I 1995-03-16
K950772 ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) Argen Precious Metals, Inc. EJT Class II 1995-03-13
K935544 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION Implant Innovations International, Inc. DZE Class II 1995-03-13
K950765 COMPA LAB-R Robert W. Bauer & Assoc., Inc. EBF Class II 1995-03-13
K944943 OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL Opti-Max DZE Class II 1995-03-13
K950556 FUJI ORTHO LC GC America, Inc. DYH Class II 1995-03-08
K943942 TRAV-LER KIT John O. Butler Co. JEQ Class I 1995-03-08
K950121 FRANCE ORTHODONTIE France Orthodontie DZB Class II 1995-03-08
K944683 BRANEMARK SYSTEM 3.3MM FIXTURE Nobelpharma USA, Inc. DZE Class II 1995-03-08
K950512 AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT American Dental Products, Inc. DYH Class II 1995-03-07
K946032 FLUOR PROTECTOR Ivoclar North America, Inc. LBH Class II 1995-03-07
K950514 TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT 3M Unitek DYH Class II 1995-03-07
K944466 SEALDENT Scientific Pharmaceuticals, Inc. EBI Class II 1995-03-02
K946187 SPIRIT II AND SPIRIT TREATMENT CENTER Pelton & Crane Co. EIA Class I 1995-03-01
K931845 SANDBLASTER Mirage Dental Systems KOJ Class II 1995-03-01
K946113 IMPLANT BODY RETRIEVER/REMOVER O Co., Inc. DZE Class II 1995-03-01
K943984 KIS-II NON-ANGULATED ABUTMENTS Implant Center of the Palm Beaches DZE Class II 1995-03-01
K943971 KIS-II IMPLANT FIXTURES Implant Center of the Palm Beaches DZE Class II 1995-03-01
K946129 IMPLANT BODY DEPTH GAUGE/TRYIN O Co., Inc. DZE Class II 1995-03-01
K944964 BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM Nobelpharma USA, Inc. DZE Class II 1995-02-28
K944069 RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1995-02-28
K942870 ULTIMA 2 DENTAL CHAIR Dentech Corp. KLC Class I 1995-02-27
K944962 BRANEMARK SYSTEM 17 ANGULATED ABUTMENT Nobelpharma USA, Inc. DZE Class II 1995-02-27
K945451 HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE Shofu Dental Corp. EMA Class II 1995-02-27
K943905 PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER Professional Positioners, Inc. EBI Class II 1995-02-27
K950428 VIVAGLASS BASE Ivoclar North America, Inc. EMA Class II 1995-02-17
K944963 BRANEMARK SYSTEM SMILINE II Nobelpharma USA, Inc. DZE Class II 1995-02-17
K945300 ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT O Co., Inc. DZE Class II 1995-02-16
K950309 EAGLE Aalba Dent, Inc. EJI Class II 1995-02-16
K946317 HARRY J. BOSWORTH RESIN I. Harry J. Bosworth Co. EBI Class II 1995-02-16
K944904 PARRALLEL PIN O Co., Inc. DZE Class II 1995-02-16
K950310 ENDURE Aalba Dent, Inc. EJT Class II 1995-02-16
K946073 ORALVUE DENTAL MIRROR Hines Group , Ltd. EAX Class I 1995-02-16
K945834 PROPHY PRO. Hyman, Phelps & McNamara, P.C. EGS Class I 1995-02-13
K942667 DENT-O-CRYL ORTHODONTIC ACRYLIC Dentauraum, Inc. KMY Class I 1995-02-13
K926354 ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Corp. DZE Class II 1995-02-13
K932932 SNOREMASTER SNORE REMEDY The Snoremaster Co. LQZ Class II 1995-02-10
K950060 PROVILINK Ivoclar North America, Inc. EMA Class II 1995-02-10
K941780 ORTHOVITA BIOGRAN Orthovita Co. LYC Class II 1995-02-10
K942993 THERMORESIN LC II GC America, Inc. EBF Class II 1995-02-07
K950030 HELIODENT MD Pelton & Crane Co. EAP Class II 1995-02-03
K945366 PARAPOST CEMENT Coltene/Whaledent, Inc. EMA Class II 1995-02-02
K950203 PROTEMP(R) GARANT Espe GmbH & Co. Kg. EBG Class II 1995-02-02
K944068 RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) Lifecore Biomedical, Inc. DZE Class II 1995-02-02
K945711 EXCEL-P FORMULA AUTO-CURE DENTURE BASE St. George Technology, Inc. EBI Class II 1995-02-02
K945535 GLENROE ORTHO-SIL Glenroe Technologies EGD Class I 1995-01-27
K946255 THERMASET Ormco Corp. DYH Class II 1995-01-27
K942480 M4 CONTRA-ANGLE HANDPIECE Kerr Corporation (Danbury) EGS Class I 1995-01-27
K946307 CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE Confi-Dental Products Co. EBF Class II 1995-01-26
K945248 HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH Hukuba Dental Corp. JEQ Class I 1995-01-26
K946137 PULPDENT PERIODONTAL DRESSINGS Pulpdent Corp. EMA Class II 1995-01-26
K941915 ORAL STEEL CARTRIDGE SYRINGE Robert W. Bauer & Assoc., Inc. EJI Class II 1995-01-26
K946100 FUJI DUET GC America, Inc. EMA Class II 1995-01-20
K946138 PULPDENT ROOT CANAL SEALER Pulpdent Corp. KIF Class II 1995-01-20
K940368 CANAL KING (THIN) CANAL KING (THICK) Pulpdent Corp. KIF Class II 1995-01-20
K945378 PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT Pulpdent Corp. EBC Class II 1995-01-17
K945220 AMALGAM CARRIER Buffalo Dental Mfg. Co., Inc. EKI Class I 1995-01-11
K945142 POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) Scican ELW Class II 1995-01-11
K943071 THE TITANIUM FIXATION SYSTEM Biomedics JEY Class II 1995-01-06
K945604 ECLIPTOMER Bisco, Inc. KLE Class II 1995-01-03
K945712 VERABOND V Aalba Dent, Inc. EJH Class II 1994-12-29
K945364 DYRACT(TM) MATERIAL Denstply Detrey-Dedent EBF Class II 1994-12-29
K945539 OPTIGUARD Sybron Dental Specialties, Inc. EBF Class II 1994-12-29
K945713 VERABOND II Aalba Dent, Inc. EJH Class II 1994-12-29
K945910 QUEST 2 AND 20 Aalba Dent, Inc. EJT Class II 1994-12-29
K945769 TOTAL ETCH GEL Dentsply Intl. EBF Class II 1994-12-29
K940950 KAVO SYSTEMATICA 1060 Kavo America KLC Class I 1994-12-29
K945401 WHITE STAR Jeneric/Pentron, Inc. EJT Class II 1994-12-29
K940261 LYNX LOW-SPEED HANDPIECE Mti Precision Products EFB Class I 1994-12-29

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