meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1994-08-23

Clearances · page 87 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935885 ELITE FAST PUTTY SOFT Zhermack Dental Production ELW Class II 1994-08-23
K942076 TONGUE SCRAPER Maharishi Ayur-Ved LCN Class I 1994-08-23
K943245 SPIRIT MB Sybron Dental Specialties, Inc. DYW Class II 1994-08-23
K943373 PERMAGEN F/DC Ultradent Products, Inc. KLE Class II 1994-08-23
K942519 UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS Bull Frog Mfg. Co. ECB Class I 1994-08-23
K942727 ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE Wallace A. Erickson & Co. DYH Class II 1994-08-23
K943574 CAPTURE IMPRESSION MATERIAL Dentsply Intl. ELW Class II 1994-08-23
K935888 ELITE FAST LIGHT BODY Zhermack Dental Production ELW Class II 1994-08-23
K935884 ELITE PUTTY SOFT Zhermack Dental Production ELW Class II 1994-08-23
K943068 MAGNEFORCE Ormco Corp. ECO Class I 1994-08-17
K940769 DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR Terraflex DYN Class I 1994-08-17
K941849 PROVIPONT C&B Ivoclar USA, Inc. EBG Class II 1994-08-17
K934645 RADWORKS Radworks Corp. EAP Class II 1994-08-17
K935137 TEFGEN-FD American Custom Medical, Inc. NPK Class II 1994-08-15
K943475 ULTRA HYDROPHILIC ALGINAE Essential Dental Systems, Inc. ELW Class II 1994-08-12
K942219 ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS Robert W. Bauer & Assoc., Inc. ELW Class II 1994-08-12
K943165 CLEARFIL PHOTO BOND Kuraray Company, Ltd. KLE Class II 1994-08-10
K943169 CLEARFIL AP-X AND LINER BOND 2 Kuraray Company, Ltd. EBF Class II 1994-08-10
K941716 MICRODONTIC LENS New Image Industries, Inc. EIA Class I 1994-08-10
K943487 BIO74-PF CROWN & BRIDGE ALLOY Jeneric/Pentron, Inc. EJT Class II 1994-08-10
K943168 CLEARFIL AP-X Kuraray Company, Ltd. EBF Class II 1994-08-10
K942203 OTC DENTURE CLEANSER Combe, Inc. EFT Class I 1994-08-10
K943167 CLEARFIL NEW BOND Kuraray Company, Ltd. KLE Class II 1994-08-10
K943170 CLEARFIL LINER BOND 2 Kuraray Company, Ltd. KLE Class II 1994-08-10
K935625 ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE Wallace A. Erickson & Co. DYH Class II 1994-08-10
K942666 ORTHALGENAT IMPRESSION MATERIAL Dentauraum, Inc. ELW Class II 1994-08-10
K943166 CLEARFIL LINER BOND SYSTEM Kuraray Company, Ltd. KLE Class II 1994-08-10
K931785 BRANEMARK SYSTEM DRILL CONTROLLER Nobelpharma USA, Inc. DZE Class II 1994-08-09
K934827 BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM Nobelpharma USA, Inc. DZE Class II 1994-08-08
K934495 BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETE Nobelpharma AB DZE Class II 1994-08-08
K934825 BRANEMARK SYSTEM Nobelpharma USA, Inc. DZE Class II 1994-08-08
K934826 BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104 Nobelpharma USA, Inc. DZE Class II 1994-08-08
K913255 CERAMIC(TM) ABUTMENT Ceramic Core Corp. DZE Class II 1994-08-05
K934781 BVR HIGH TORQUE HEADS Bvr Aero Precision Corp. EGS Class I 1994-08-05
K934468 SLIP-ON FIXATION SPLINT (SFS) Gatewood Splints EHO Class I 1994-08-05
K933542 MESIAL LOOP BAR Gac Intl., Inc. ECO Class I 1994-08-05
K942528 INTEGRAPOST Dental Logics, Inc. ELR Class I 1994-08-05
K940864 DENTIST WITH ASSISTANT PACK Sterile Concepts, Inc. EIA Class I 1994-08-02
K925766 BRANEMARK SYSTEM TEMPORARY SOLUTIONS Nobelpharma USA, Inc. DZE Class II 1994-08-02
K941532 BIOCALEX 6/9 Bio-Probe, Inc. EJK Class II 1994-08-02
K943213 ARGIPLUS LO Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943264 SOLDER #205 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943271 SOLDER #206 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943214 SOLDER #204 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943212 ARGESOL #830Y Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943211 ARGESOL 750Y Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943208 ARGESOL 750PY Argen Precious Metals, Inc. EJT Class II 1994-08-01
K936151 EXTRAORAL HEADGEAR Dentauraum, Inc. DZB Class II 1994-08-01
K943209 ARGESOL PNP Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943210 ARGESOL #1005Y Argen Precious Metals, Inc. EJT Class II 1994-08-01
K925490 INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1994-08-01
K934571 BVR CONTRA-ANGLE HANDPIECE Bvr Aero Precision Corp. EGS Class I 1994-08-01
K943267 SOLDER #211 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K943269 SOLDER #209 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K936221 PROBE TIP/PERI PROBE/PERI PROBE COMP. Pd International AB EIX Class I 1994-08-01
K943273 TRI HAWK BUR, FG BUR Tri Hawk Corp. EJL Class I 1994-08-01
K943266 SOLDER #210 Argen Precious Metals, Inc. EJT Class II 1994-08-01
K936068 ORTHOPHOS 3/ ORTHOPHOS 3C Pelton & Crane Co. EAP Class II 1994-07-29
K934728 SUNSOR ULTRAVIOLET METER Sunsor, Inc. EAQ Class II 1994-07-28
K935127 SOUTHLAND STERILE DENTAL SYSTEM Southland, Ltd. EKJ Class I 1994-07-28
K941349 DENTAL TRAY Cush Medical Products EIA Class I 1994-07-26
K922872 INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. Interpore Intl. DZE Class II 1994-07-25
K941554 SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1994-07-22
K942978 ARGESOL #650 Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942929 ARGESOL LO Argen Precious Metals, Inc. EJT Class II 1994-07-22
K943088 ARGESOL R Argen Precious Metals, Inc. EJT Class II 1994-07-22
K932759 TEMPOARY POLYCARBONATE CROWNS South American Dental Exporting Corp. ELZ Class I 1994-07-22
K942979 ARGESOL-ARGICRAFT-1 Argen Precious Metals, Inc. EJT Class II 1994-07-22
K930835 VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A Ivoclar North America, Inc. ELL Class II 1994-07-22
K943089 ARGESOL 830W Argen Precious Metals, Inc. EJT Class II 1994-07-22
K943087 ARGESOL 750W Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942668 O-TRAY IMPRESSION TRAYS Dentauraum, Inc. EHY Class I 1994-07-22
K942943 ARGESOL-NOVASOL Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942981 ARGESOL #585 Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942980 ARGESOL #615 Argen Precious Metals, Inc. EJT Class II 1994-07-22
K943032 AURIUM Y+ Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942665 ORTHOCENT: LIQUID AND POWDER Dentauraum, Inc. EMA Class II 1994-07-22
K943037 ARGEDENT 41 Argen Precious Metals, Inc. EJT Class II 1994-07-22
K942928 ARGESOL 500 Argen Precious Metals, Inc. EJT Class II 1994-07-21
K942859 ARGESOL-YPF Argen Precious Metals, Inc. EJT Class II 1994-07-21
K934049 BII-PORE(TM) CANAL WALL PROSTHESIS Bio-Interfaces, Inc. LYC Class II 1994-07-19
K933688 BII-PORE Bio-Interfaces, Inc. LYC Class II 1994-07-19
K942430 AGALLOY, DISALLOY, EPSILON AND LAMBDA Fen Dental Mfg., Inc. EJJ Class II 1994-07-14
K942492 ADJUSTABLE BITE CORRECTOR Orthoplus, Inc. ECO Class I 1994-07-13
K934500 METASYS AMALGAM SEPARATOR MST1 Metasys Dental Products, Inc. EIA Class I 1994-07-13
K924112 HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II Saber Technology, Inc. DZE Class II 1994-07-12
K941431 BONE GRAFT DELIVERY SYRINGES Bio-Interfaces, Inc. EID Class I 1994-07-12
K931468 RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM Lifecore Biomedical, Inc. DZE Class II 1994-07-12
K940893 A-DEC RADIUS 2122/2132 A-Dec, Inc. EIA Class I 1994-07-12
K941954 NON-FOGGING DENTAL MIRROR Buffalo Dental Mfg. Co., Inc. EKJ Class I 1994-07-08
K942767 ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN Wallace A. Erickson & Co. EBF Class II 1994-07-08
K942521 CONSERVA POST SYSTEM Bull Frog Mfg. Co. ELR Class I 1994-07-08
K930071 SARGON CYLINDRO-BLADE IMPLANT Sargon Ent., Inc. DZE Class II 1994-07-08
K942017 V-PRIMER Parkell, Inc. KLE Class II 1994-07-06
K942672 STERI-LUBE Petroleum Products of America EFB Class I 1994-07-06
K931539 NORMED TITANIUM MINIPLATE SYSTEM Normed Medizin-Technik GmbH JEY Class II 1994-07-05
K941899 SDI COMPOSTIES Southern Dental Industries, Inc. EBF Class II 1994-07-05
K942493 SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM 3M Company KLE Class II 1994-07-05
K925115 AMD DENTIST AND HYGIENIST KITS Advance Medical Designs, Inc. EKJ Class I 1994-07-05
K926101 PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO Phoenix Dental, Inc. DZE Class II 1994-06-23

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