meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
49
Latest Decision
1994-02-03

Clearances · page 90 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935687 NIL Dentalsafe Systems Pty., Ltd. EAX Class I 1994-02-03
K934981 DENTAL DRILL Eare Consulting Service DZP Class I 1994-02-03
K935154 DENTAURUM EXPANSION SCREWS Dentauraum, Inc. DYJ Class I 1994-02-03
K935156 DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS Dentauraum, Inc. ECR Class I 1994-02-03
K936244 REGENCY BRACKET Mid-American Dental Specialties, Inc. EJF Class I 1994-02-02
K936243 REGENCY TUBE Ortho Specialties DZD Class I 1994-02-02
K930335 PROFAST - DENTURE ADHESIVE FOR LOWER JAWS Fittydent-Altwirth & Schmitt GmbH KOO Class I 1994-02-01
K934881 REFLECTIONS Cdb Corp. EJF Class I 1994-02-01
K934815 AIR COMPRESSOR, MODEL PAC 6.7 Defiance Electronics, Inc. EIA Class I 1994-02-01
K933623 EUREKA J.F. Jelenko & Co., Inc. EJT Class II 1994-02-01
K930872 ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA Wallace A. Erickson & Co. KIF Class II 1994-02-01
K923705 AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS Aesculap, Inc. JEY Class II 1994-02-01
K935143 DENTAURUM STAINLESS STEEL TUBING Dentauraum, Inc. DZD Class I 1994-01-31
K935148 SONIFLOSS American Dentronics, Inc. JEQ Class I 1994-01-31
K935122 DENTAURUM METAL BRACKETS Dentauraum, Inc. EJF Class I 1994-01-31
K935153 DENTAURUM BRACKET POSITIONING GAUGE Dentauraum, Inc. ECQ Class I 1994-01-31
K935152 DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD Dentauraum, Inc. DYO Class I 1994-01-31
K923534 PM2002 PROLINE Planmeca USA, Inc. KLC Class I 1994-01-31
K935141 DENTAURUM PLIERS Dentauraum, Inc. JEX Class I 1994-01-31
K933455 COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. EAP Class II 1994-01-31
K925080 TEK-LUBE Clinical Technology Corp. EFB Class I 1994-01-31
K935149 SONIBRUSH American Dentronics, Inc. JEQ Class I 1994-01-31
K925119 A-DEC 1040 CHAIR A-Dec, Inc. KLC Class I 1994-01-31
K935142 DENTAURUM WIRES Dentauraum, Inc. DZC Class I 1994-01-31
K935973 ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND BRIDGE APPLICATION Argen Precious Metals, Inc. EJT Class II 1994-01-28
K932829 CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST Alpha-Dent EBF Class II 1994-01-28
K932826 CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO Alpha-Dent EBF Class II 1994-01-28
K931329 DENTAL INSTRUMENTS CURETTE PERIODONTAL Minnesota Prophy Power, Inc. EMS Class I 1994-01-27
K931330 DENTAL INSTRUMENTS SCALER Minnesota Prophy Power, Inc. EMN Class I 1994-01-26
K935736 CHARISMA SUPERLIGHT Heraeus Kulzer, Inc. EBF Class II 1994-01-26
K935718 JEDENTAL VLC DENTAL CURING LIGHT Jedental Co., Inc. EAY Class I 1994-01-26
K926427 LARIAT PALATE EXPANDER Easy Access Orthodontics, Inc. EJF Class I 1994-01-26
K922249 FLEXI-FLOW CEMENT NATURAL Essential Dental Systems, Inc. EMA Class II 1994-01-26
K935261 KOOLINER II GC America, Inc. EBI Class II 1994-01-26
K936076 ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH Ohio Health Care Products, Inc. JEQ Class I 1994-01-26
K935925 VISION PROPHY PASTE WITH FLUORIDE Block Drug Company, Inc. EJR Class I 1994-01-26
K922251 TI-CORE-NATURAL Essential Dental Systems, Inc. EBF Class II 1994-01-26
K926081 DENTAL LIGHT Mdt Corp., Inc. EAZ Class I 1994-01-26
K922250 FLEXI-FLOW CEMENT WITH TITANIUM Essential Dental Systems, Inc. EMA Class II 1994-01-26
K935522 RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE Ranir/Dcp Corp. JES Class I 1994-01-26
K925028 FORESTADENT ORTHODONTIC BANDS Forestadent EJF Class I 1994-01-26
K935972 ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION) Argen Precious Metals, Inc. EJH Class II 1994-01-26
K934073 JEDENTAL GLASS IONOMER CEMENT AND LINER Jedental Co., Inc. EMA Class II 1994-01-26
K931440 CALCITEK TORQUE WRENCH SYSTEM Calcitek, Inc. DZE Class II 1994-01-26
K935508 ARGEDENT 78PF Argen Precious Metals, Inc. EJT Class II 1994-01-26
K933766 HIGH-Q-BOND Silmet U.S.A. Corp. EBF Class II 1994-01-26
K935829 ARGELOY PARTIAL (NON-PRECIOUS) Argen Precious Metals, Inc. EJH Class II 1994-01-26
K935507 ARGEDENT 77PF Argen Precious Metals, Inc. EJT Class II 1994-01-26
K934947 BII-PLAST Bio-Interfaces, Inc. LYC Class II 1994-01-26
K935561 INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT Bausch & Lomb, Inc. JEQ Class I 1994-01-26
K933745 PERMAGEN UNIVERSAL BONDING RESIN Bio-Systems Research EBH Class I 1994-01-26
K934596 BISCO DUO LINK D/C LUTING COMPOSITE Bisco, Inc. KLE Class II 1994-01-26
K922252 TI-CORE NEW & IMPROVED Essential Dental Systems, Inc. EBF Class II 1994-01-26
K935041 3M TEMPORARY CROWN & BRIDGE MATERIAL 3M Company EBG Class II 1994-01-26
K932111 DENTAL X-RAY UNIT Castellini S.P.A. EHD Class II 1994-01-25
K932600 MODIFIED SITE POWER HANDPIECE II Chiron Vision Corp. EKX Class I 1994-01-25
K925746 REPLICA Matech, Inc. ELW Class II 1994-01-21
K935714 CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE Confi-Dental Products Co. DYH Class II 1994-01-21
K934265 FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE Flexmedics DZC Class I 1994-01-21
K931093 QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE Dentalez Group EIA Class I 1994-01-21
K930939 REBARON LC GC America, Inc. EBI Class II 1994-01-21
K934405 PRECEDENT Reliance Orthodontic Products, Inc. EMA Class II 1994-01-21
K935727 P&FS PIT AND FISSURE SEALANT Jedental Co., Inc. EBC Class II 1994-01-21
K924716 NICO DENTAL ALLOY Co-Nick Alloys (India) , Ltd. EJH Class II 1994-01-21
K930881 CHANNEL-EDGE BRACKET SYSTEM Dualtek, Inc. EJF Class I 1994-01-21
K935689 IONOSIT BASE LINER Foremost Dental Mfg., Co. EBD Class II 1994-01-21
K933507 NEEDLETUBE SYRINGE CARTRTIDGE Centrix, Inc. EJK Class II 1994-01-18
K934019 EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO St. George Technology, Inc. EBI Class II 1994-01-18
K933758 REGENCY PLUS BRACKET Mid-American Dental Specialties, Inc. EJF Class I 1994-01-18
K935032 ZENITH TOTAL ETCH 10% PHOSPHORIC ACID Foremost Dental Mfg., Inc. EBF Class II 1994-01-18
K926190 ALRAND INC. (DENTAL HAND INSTRUMENTS) Alrand, Inc. EJP Class I 1994-01-18
K922652 ACE BASIC DENTAL IMPLANT PACK I Ace Surgical Supply Co., Inc. EIA Class I 1994-01-10
K922651 ACE DENTAL IMPLANT KIT Ace Surgical Supply Co., Inc. EIA Class I 1994-01-10
K922650 ACE DENTAL IMPLANT CUSTOM SURGICAL PACK Ace Surgical Supply Co., Inc. EIA Class I 1994-01-10
K922649 ACE BASIC DENTAL IMPLANT PACK II Ace Surgical Supply Co., Inc. EIA Class I 1994-01-10
K933505 BOSWORTH COPALIONER Harry J. Bosworth Co. LBH Class II 1994-01-07
K933670 BIOPSY PUNCH, SURGICAL Byron Medical EME Class I 1994-01-07
K915612 ARGENCO Y + Argen Precious Metals, Inc. EJT Class II 1994-01-07
K930248 VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM Crown Delta Corp. ELW Class II 1994-01-07
K925797 A-DEC 2544 DOCTORS IC MICRO-CART A-Dec, Inc. EIA Class I 1994-01-06
K933199 CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL Confi-Dental Products Co. EMA Class II 1994-01-06
K924351 GLENROE ELASTIBITE STIMULATOR Glenroe Technologies KMY Class I 1994-01-06
K935387 PONTOR LFC Metalor EJT Class II 1994-01-06
K934746 3M CURING LIGHT XL1500 3M Company EBZ Class II 1994-01-06
K935521 GC ELITE CEMENT GC America, Inc. EMA Class II 1994-01-06
K925798 A-DEC 2545 DUO IC MICRO-CART A-Dec, Inc. EIA Class I 1994-01-06
K932878 PRECISION INTRA-ORAL SCOPES Precise Optics EIA Class I 1994-01-06
K935388 CERAPALL 4CF Metalor EJS Class II 1994-01-06
K933139 3M VITREMER LUTING CEMENT 3M Company EMA Class II 1994-01-05
K935217 LC DENTAL HAND INSTRUMENT L.C. Dental EKJ Class I 1994-01-05
K933999 STERIBASE (ACCUBASE) Centrix, Inc. EJK Class II 1994-01-05
K933468 MYERSON'S PERMASOFT SOFT RELINE MATERIAL Austenal, Inc. EBI Class II 1994-01-05
K935542 NICKEL-TITANIUM K-TYPE FILE Union Broach, Div. Moyco Industries, Inc. EKS Class I 1994-01-03
K934690 KERR OPTIBOND, MODIFICATION Kerr Corporation (Danbury) KLE Class II 1993-12-30
K934063 PANORAMIC X-RAY UNITS, MODIFICATION Planmeca Oy EHD Class II 1993-12-15
K934184 FASTFIL Scientific Pharmaceuticals, Inc. EMA Class II 1993-12-13
K933829 PULSE ELECTRIC TOOTHBRUSH Dentatech Corp. JEQ Class I 1993-12-13
K923484 STERI-OSS TITANIUM SCREW SERIES IMPLANT Steri-Oss, Inc. DZE Class II 1993-12-13
K934978 FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL Ivoclar North America, Inc. EBG Class II 1993-12-10
K934283 DENTALON PLUS MODIFICATION Heraeus Kulzer, Inc. EBG Class II 1993-12-10

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