meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
1994-06-22

Clearances · page 88 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K924589 RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Implant Support Systems, Inc. DZE Class II 1994-06-22
K942589 ARGESOL P Argen Precious Metals, Inc. EJT Class II 1994-06-22
K941625 DW234 #29 Rms Div. EJS Class II 1994-06-22
K942590 ARGESOL W Argen Precious Metals, Inc. EJT Class II 1994-06-22
K926102 PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN Phoenix Dental, Inc. DZE Class II 1994-06-22
K942595 ARGELITE PF+ Argen Precious Metals, Inc. EJT Class II 1994-06-22
K934668 ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL) Zest Anchors, Inc. DZE Class II 1994-06-22
K942505 ARGESOL-WSF PRE-SOLDER FOR HIGH GOLD DENTAL PROCELAIN ALLOYS Argen Precious Metals, Inc. EJT Class II 1994-06-16
K942540 ARGESOL-WG Argen Precious Metals, Inc. EJT Class II 1994-06-16
K942557 ARGESOL-1060W Argen Precious Metals, Inc. EJT Class II 1994-06-16
K941209 MY BEAT POWERED TOOTHBRUSH Sanwa Components USA, Inc. JEQ Class I 1994-06-16
K942507 ARGESOL-Y Argen Precious Metals, Inc. EJT Class II 1994-06-16
K941065 DEOX, OXYGEN BARRIER VISCOUS SOLUTION Ultradent Products, Inc. EMA Class II 1994-06-16
K942596 ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT Wallace A. Erickson & Co. EMA Class II 1994-06-16
K942538 ARGESOL-1040Y Argen Precious Metals, Inc. EJT Class II 1994-06-16
K942539 ARGESOL-LITE Argen Precious Metals, Inc. EJT Class II 1994-06-16
K942462 ARGESOL-YSF PRE-SOLDER FOR HI GOLD DENT PORCEL ALLOYS Argen Precious Metals, Inc. EJT Class II 1994-06-16
K933737 DURODENT CORPORATION ARTIFICIAL PLASTIC TEETH Durodent Corp. ELM Class II 1994-06-13
K942393 TUBLI-SEAL EWT Sybron Dental Specialties, Inc. KIF Class II 1994-06-10
K941452 ULTRACAM II Dental Vision Direct, Inc. EIA Class I 1994-06-10
K942031 CAULK TOOTH CONDITIONER GEL AND SYRINGE Dentsply Intl. EBF Class II 1994-06-10
K935436 ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED Wallace A. Erickson & Co. EMA Class II 1994-06-10
K922627 GORE-TEX REGENERATIVE MATERIAL W. L. Gore & Associates, Inc. NPK Class II 1994-06-10
K941572 FLUORIDE-PSA PRIME/ADHESIVE Dentsply Intl. KLE Class II 1994-06-10
K941243 ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH Oraline, Ltd. JEQ Class I 1994-06-06
K934192 PARAPOST XT SYSTEM Coltene/Whaledent, Inc. ELR Class I 1994-06-06
K941009 DISPOSABLE PROPHY ANGLE Allpro, Inc. EGS Class I 1994-06-06
K940737 EDTA GEL (TM) Karolinska Institutet EBF Class II 1994-06-03
K942199 CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd. EBZ Class II 1994-06-02
K934436 SBP DENTAL UNIT Northland Dental Engineering EIA Class I 1994-06-02
K932123 IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM Implant Innovations International, Inc. DZE Class II 1994-05-27
K942198 CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 Rolence Enterprise Co. , Ltd. EBZ Class II 1994-05-27
K941925 ORTHO-JET ACRYLIC RESIN - SPARKLE Lang Dental Mfg. Co., Inc. EBI Class II 1994-05-27
K940860 CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS Ultradent Products, Inc. ELW Class II 1994-05-27
K922931 THERMAPOST ENDODONTIC ROOT CANAL POST Tulsa Dental Products, Ltd. ELR Class I 1994-05-26
K940288 WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT Teledyne Water Pik JEQ Class I 1994-05-26
K941392 JET UNIT (CJ HANDPIECE) Dentsply Intl. ELC Class II 1994-05-23
K925312 HAND INSTRUMENT CALCULUS REMOVAL Implant Support Systems, Inc. DZE Class II 1994-05-23
K925796 SPIRAL LOCK DENTAL IMPLANT SYSTEM Robert A James DZE Class II 1994-05-23
K926100 SPIRAL LOCK DENTAL IMPLANT SYSTEM Robert A James DZE Class II 1994-05-23
K941164 TAP EXPRESS EJECTOR Tap Express, Inc. EHZ Class I 1994-05-18
K934430 BON APATITE HA PARTICLES Bio-Interfaces, Inc. LYC Class II 1994-05-18
K941574 RETRO MIRROR Union Broach, Div. Moyco Industries, Inc. EAX Class I 1994-05-18
K923694 DUO DENT Pdc Management Services, Inc. DZE Class II 1994-05-18
K935150 SONIPLAK American Dentronics, Inc. JEQ Class I 1994-05-18
K935638 NITINOL, NITI Highland Metals DZC Class I 1994-05-18
K934783 KAVO INTRASEPT 905 Kavo America EIA Class I 1994-05-16
K941189 DISPOSABLE PROPHYLAXIS ANGLE Team Technologies, Inc. EGS Class I 1994-05-16
K936058 OPTODENT/OPTOGNATH Spectrum Healthcare Group ELM Class II 1994-05-16
K923711 PERIOFLEX TIP Novadent, Ltd. EFS Class I 1994-05-16
K932825 MICROARCH GOLD BRACKET Gac Intl., Inc. EJF Class I 1994-05-09
K940565 COE-SOFT LC GC America, Inc. EBI Class II 1994-05-04
K941377 CONQUEST SMOOTH TOUCH Jeneric/Pentron, Inc. EBF Class II 1994-05-03
K941373 PENT CORE PLUS (PASTE-PASTE) Jeneric/Pentron, Inc. EBF Class II 1994-05-03
K941375 CONQUEST GINGA-BLEND Jeneric/Pentron, Inc. EBF Class II 1994-05-02
K941374 CONQUEST PRELUDE Jeneric/Pentron, Inc. EBF Class II 1994-05-02
K940244 VERIDENT PLUS, OPTIFORM Lactona Corp. ELM Class II 1994-05-02
K925483 BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276 Nobelpharma USA, Inc. DZE Class II 1994-05-02
K940122 HY BOND, GLASIONOMER CX Shofu Dental Corp. EMA Class II 1994-05-02
K941378 PROCOM Jeneric/Pentron, Inc. EBF Class II 1994-05-02
K941376 CONQUEST SENIOR Jeneric/Pentron, Inc. EBF Class II 1994-05-02
K941072 AURIUM PC16 Argen Precious Metals, Inc. EJT Class II 1994-04-29
K940546 GRANITEC IONOMER RESIN CEMENT Confi-Dental Products Co. EMA Class II 1994-04-29
K940599 DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT Q. C. Filter, Inc. EIA Class I 1994-04-29
K940675 SYBRALOY Sybron Dental Specialties, Inc. EJJ Class II 1994-04-29
K924830 LUXATEMP AUTOMIX Dmg Chemisch Pharmazeutische Fabrik GmbH EBG Class II 1994-04-29
K941097 AURIUM D16 Argen Precious Metals, Inc. EJT Class II 1994-04-29
K940459 MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) Dentsply Intl. EMA Class II 1994-04-29
K941067 AUROLITE CB Argen Precious Metals, Inc. EJT Class II 1994-04-29
K933501 ALASTIK Unitek Corp. EJF Class I 1994-04-28
K941068 AUROLITE CB80 Argen Precious Metals, Inc. EJT Class II 1994-04-28
K941069 AUROLITE MT1 Argen Precious Metals, Inc. EJT Class II 1994-04-28
K932243 GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO Precious Chemicals U.S.A., Inc. EJT Class II 1994-04-28
K940685 PRETREATMENT SOLUTION Dentsply Intl. ELW Class II 1994-04-28
K935856 DENTAURUM SPACE MAINTAINER Dentauraum, Inc. DYT Class I 1994-04-28
K931396 DENTAL SCREW POSTS Harald Nordin S.A ELR Class I 1994-04-28
K941071 AUROLITE CB25 Argen Precious Metals, Inc. EJT Class II 1994-04-28
K941070 AUROLITE CB+2 Argen Precious Metals, Inc. EJT Class II 1994-04-28
K931993 ITI DISTANCE SYSTEM The Straumann Co. DZE Class II 1994-04-26
K933969 TAPERED ABUTMENT AND RELATED COMPONENTS Implant Innovations, Inc. DZE Class II 1994-04-26
K932997 MICROPREP CAVITY PREPERATION SYSTEM Sunrise Technologies, Inc. KOJ Class II 1994-04-25
K934126 ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS Implant Innovations, Inc. DZE Class II 1994-04-25
K941365 MPI DENTURE ADHESIVE FILM SEALS Medical Polymers, Inc. KOT Class I 1994-04-22
K923372 MEMORY WIRE Althan, Inc. EJF Class I 1994-04-22
K935325 A-DEC CASCADE 3072 WALLMOUNT A-Dec, Inc. EIA Class I 1994-04-21
K940496 PROPHY PASTE Challenge Products, Inc. EJR Class I 1994-04-19
K932255 YOUNG D'GRANULATOR Young Dental Manufacturing Co. 1, LLC KMW Class II 1994-04-15
K940513 OPTIBOND Kerr Corporation (Danbury) KLE Class II 1994-04-15
K941124 STRUCTUR 2 Voco GmbH EBG Class II 1994-04-13
K925367 A-DEC 7284 CUSPIDOR, CASCADE A-Dec, Inc. EBR Class I 1994-04-11
K922683 PRESTYL JET INJECTOR Bma Technologies S.A. EJI Class II 1994-04-11
K925700 ZEST ANCHOR ADVANCED GENERATION Zest Anchors, Inc. EGG Class I 1994-04-07
K940800 DENTACOLOR VITA (VS) SHADE SYSTEM Heraeus Kulzer, Inc. EBF Class II 1994-04-07
K940930 AURIUM G14 Argen Precious Metals, Inc. EJT Class II 1994-04-04
K935151 HYDROCOLLOID HEATING UNIT Centrix, Inc. ELW Class II 1994-04-04
K941002 AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY) Argen Precious Metals, Inc. EJT Class II 1994-03-31
K941003 AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY) Argen Precious Metals, Inc. EJT Class II 1994-03-31
K940865 AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY) Argen Precious Metals, Inc. EJT Class II 1994-03-31
K941015 ORMCO SYSTEM 1+ (TM) Ormco Corp. DYH Class II 1994-03-31
K926165 CERAMCO CROWNS AND BRIDGES Asap Dental Lab, Ltd. EJH Class II 1994-03-31

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