meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
2011-10-14

Clearances · page 36 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111120 CSM SUBMERGED-R IMPLANT SYSTEM Csm Implant DZE Class II 2011-10-14
K111980 CLEARFIL TRI-S BOND PLUS Kuraray America, Inc. KLE Class II 2011-10-14
K111532 MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE Anthogyr Sas EGS Class I 2011-10-07
K102871 SILVER CARE ANITBACTERIAL TOOTHBRUSH Piave Spazzolificio S.P.A. EFW Class I 2011-10-03
K111169 PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF Kwang Myung Daicom, Inc. DZB Class II 2011-10-03
K111357 STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 2011-10-03
K110308 PROSTHETIC SYSTEM Osstem Implant Co., Ltd. NHA Class II 2011-10-03
K111832 PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID Heraeus Kulzer, LLC EBI Class II 2011-09-29
K111816 EQUIMATRIX Luitpold Pharmaceuticals, Inc. NPM Class II 2011-09-29
K111809 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS Biomaterials Korea, Inc. OAT Class II 2011-09-26
K111287 ASTRA TECH IMPLANT SYSTEM Astra Tech AB DZE Class II 2011-09-26
K112517 ULTRASEAL XT HYDRO Ultradent Products, Inc. EBC Class II 2011-09-23
K111649 CS 7600 Carestream Health, Inc. MUH Class II 2011-09-23
K111876 Z BOND, PRELUDE ONE Danville Materials, Inc. KLE Class II 2011-09-21
K103290 EDLEN IMAGING - GEMINI DUSB Edlen Imaging, LLC MUH Class II 2011-09-19
K111836 PERMASHADE VENEER CEMENT Ultradent Products, Inc. EMA Class II 2011-09-16
K111782 BEAUTISEALANT Shofu Dental Corporation EBC Class II 2011-09-16
K103089 SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS Mis - Implant Technologies , Ltd. DZE Class II 2011-09-15
K111003 BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL Biodenta Swiss AG DZE Class II 2011-09-15
K111814 PADLOCK Reliance Orthodontic Products, Inc. DYH Class II 2011-09-14
K111743 THE INSYNC CERAMIC SYSTEM Jensen Industries, Inc. EIH Class II 2011-09-14
K103810 KJ SUBMERGED SYSTEM Kj Meditech Co., Ltd. DZE Class II 2011-09-14
K103461 COLGATE DESENSITIZING DENTAL CREAM Colgate-Palmolive Co. LBH Class II 2011-09-13
K111177 JUELL HARD CURE Juell Dental EBI Class II 2011-09-12
K111724 STRAUMANN TIBRUSH Straumann USA ELB Class II 2011-09-12
K111178 JUELL SOFT CURE Juell Dental EBI Class II 2011-09-12
K111390 SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. Cendres & Metaux SA NHA Class II 2011-09-12
K110403 PROLINK ADHESIVES (PROLINK, PROLINK SE) Silmet , Ltd. KLE Class II 2011-09-08
K111666 EVADYNE TEMPORARY CROWN AND BRIDGE RESIN Neodental Chemical Products Co., Ltd. EBG Class II 2011-09-07
K111696 OPAL BAND CEMENT Ultradent Products, Inc. DYH Class II 2011-09-07
K111685 IP TEMP CEMENT Shofu Dental Corporation EMA Class II 2011-09-02
K110565 ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE Biomet 3i, Inc. NHA Class II 2011-09-01
K110756 BLUEPHASE STYLE Ivoclar Vivadent, Inc. EBZ Class II 2011-08-29
K111573 MONOBLOC BM SERIES Hass Corp. EIH Class II 2011-08-26
K103087 COVAMAX RESORBABLE COLLAGEN MEMBRANE Biom'Up Sas NPL Class II 2011-08-26
K111207 RESPIRE BLUE SERIES Respire Medical LRK Class II 2011-08-23
K103027 ELECTROTORQUE TLC Kaltenbach & Voigt GmbH EBW Class I 2011-08-19
K111616 E-CUBE Saeshin Precision Co., Ltd. EKX Class I 2011-08-19
K111668 CAVIOS CAVITY LINER Neodental Chemical Products Co., Ltd. EJK Class II 2011-08-19
K103790 ACE TRIMARK TRICAM DENTAL IMPLANT Ace Surgical Supply Company, Inc. DZE Class II 2011-08-18
K103699 EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC Exactech, Inc. NUN Class II 2011-08-12
K111383 ZIRPRIME Noritake Co., Inc. EIH Class II 2011-08-12
K110580 NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS Straumann USA NHA Class II 2011-08-12
K111852 ANODIZED HEALING COLLAR Zimmer Dental, Inc. NHA Class II 2011-08-11
K110719 ORIGIN ZIRCONIA B&D Dental Technologies EIH Class II 2011-08-11
K111199 INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS Intra-Lock International, Inc. NHA Class II 2011-08-08
K111431 B1P ADHESIVE Pentron Clinical KLE Class II 2011-08-01
K110548 OSI O-BALL ABUTMENT HEAD IMPLANTS Juell Dental DZE Class II 2011-07-29
K110778 BIODENTA CUSTOMIZED ABUTMENT Biodenta Swiss AG NHA Class II 2011-07-29
K110600 COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN Collagen Matrix, Inc. NPL Class II 2011-07-29
K111110 APNEA GUARD Advanced Brain Monitoring, Inc. LRK Class II 2011-07-22
K111009 ACRYLIC HERBST APPLIANCE Embassy Dental Laboratory LRK Class II 2011-07-22
K111152 ROTOGRAPH EVO 3D Villa Sistemi Medicali S.P.A. MUH Class II 2011-07-22
K101453 VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE Obi Biologics, Inc. NPL Class II 2011-07-21
K111291 AIDITE ZIRCONIA DENTAL CERAMICS Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. EIH Class II 2011-07-20
K110577 OSSEOFUSE DENTAL IMPLANT SYSTEM Dynamic Innovations, Inc. DZE Class II 2011-07-14
K111231 PANOURA 18S The Yoshida Dental Mfg. Co., Ltd. MUH Class II 2011-07-13
K111179 ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN Siesta Medical, Inc. ORY Class II 2011-07-01
K102573 PROVU (TM) DENTAL X-RAY SYSTEM Advanced Image Science, Inc. EAP Class II 2011-06-30
K111107 SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE Noritake Co., Inc. EIH Class II 2011-06-30
K103234 GC AADVA BO AC ABUTMENTS GC America, Inc. NHA Class II 2011-06-30
K111581 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE Nobel Biocare AB NHA Class II 2011-06-23
K110859 METAL OPAQUER Apex Dental Materials, Inc. EBF Class II 2011-06-23
K101005 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT Astra Tech AB NHA Class II 2011-06-21
K110871 FIT CHECKER ADVANCED GC America, Inc. ELW Class II 2011-06-17
K102917 FIXTEMP C&B Exacta Dental Direct, Inc. EBG Class II 2011-06-17
K110171 NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS Nobel Biocare USA, LLC NHA Class II 2011-06-15
K111078 AEU-26L ELCTRONIC ENDODONTIC SYSTEM Aseptico, Inc. EKX Class I 2011-06-14
K110747 TEMPFLEX Kerr Corporation EBG Class II 2011-06-14
K110356 ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT Astra Tech, Inc. NHA Class II 2011-06-10
K110759 TEMPOCEM Dmg USA, Inc. EMB Class I 2011-06-10
K110640 ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT Astra Tech, Inc. NHA Class II 2011-06-10
K103019 KJ MASK Kj Meditech Co., Ltd. DZB Class II 2011-06-09
K111017 CLEARTEMP Ultradent Products, Inc. EMA Class II 2011-06-06
K110753 MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM Dentsply International, Inc. EKX Class I 2011-06-06
K110275 ORTHO EASY PIN Forestadent Bernhard Forster GmbH OAT Class II 2011-06-03
K110508 SUGLUE-10 3M Espe AG EMA Class II 2011-06-03
K110642 SILJETR SYSTEM Danville Materials, Inc. EBF Class II 2011-05-27
K110589 CIMARA Voco GmbH EBF Class II 2011-05-27
K111330 AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY Skanray Technologies EHD Class II 2011-05-27
K103653 E3 TORQUE CONTROL MOTOR Dentsply International, Inc. EBW Class I 2011-05-26
K103514 PRO-V COAT Bisco, Inc. EBG Class II 2011-05-25
K102463 GOOD NIGHT Larry V Connell, Dmd LRK Class II 2011-05-25
K110335 CERAMIC BRACKETS Ortho Organizers, Inc. NJM Class II 2011-05-19
K110302 ADHESIVE EXL-759 3M Espe AG KLE Class II 2011-05-19
K110484 SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL Novocol, Inc. EBG Class II 2011-05-17
K111321 REMOTE VIEW SOFTWARE Cariescan , Ltd. NBL Class II 2011-05-17
K111257 HEISENBERG DYEING LIQUIDS 3M Espe AG EIH Class II 2011-05-13
K110449 ENDOBON XENOGRAFT GRANULES Biomet 3i LYC Class II 2011-05-13
K111234 CLICK-IT Tp Orthodontics, Inc. NJM Class II 2011-05-13
K110235 BEAUTIBOND MULTI Shofu Dental Corp. KLE Class II 2011-05-13
K110252 BEAUTIBOND MULTI PR PLUS Shofu Dental Corp. KLE Class II 2011-05-13
K101155 AURADORM (NEUROMUSCULAR SLEEP) Sleepwright LRK Class II 2011-05-12
K102208 NANOGEN Orthogen, LLC LYC Class II 2011-05-06
K111185 RELYX LUTING PLUS AUTOMIX 3M Espe Dental Products EMA Class II 2011-05-05
K102307 GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS Genoss Co., Ltd. NPL Class II 2011-05-04
K110440 QUICK UP Voco GmbH EBI Class II 2011-05-04
K110037 PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID Heraeus Kulzer, LLC EBI Class II 2011-04-29
K110582 VALO CORDLESS Ultradent Products, Inc. EBZ Class II 2011-04-28
K102517 TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS Thunder Tiger Corp. EFB Class I 2011-04-27

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