meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
2010-12-16

Clearances · page 38 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101956 STRAUMANN MEMBRAGEL Straumann USA (On Behalf of Institut Straumann Ag) NPK Class II 2010-12-16
K093299 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM Synthes (Usa) OAT Class II 2010-12-16
K100779 SUSTAIN SPACE MAINTENANCE SYSTEM Medtronic Sofamor Danek USA, Inc. JEY Class II 2010-12-13
K101465 STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR Institut Straumann AG NHA Class II 2010-12-13
K102436 NOBEL ACTIVE 3.0 Nobel Biocare AB DZE Class II 2010-12-09
K100854 PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 Premium Plus International Limited EGS Class I 2010-12-09
K102984 AURA Sdi Limited EBF Class II 2010-12-08
K102739 HYDROCOLOR 5 Cascades Device Consulting Associates ELW Class II 2010-12-08
K093749 GC AADVA IMPLANT SYSTEM GC America, Inc. DZE Class II 2010-12-06
K102252 DMP PIT & FISSURE SEALANT Dmp, Ltd. EBC Class II 2010-12-03
K100731 BOSWORTH AIR POLISHER Harry J. Bosworth Co. EFB Class I 2010-12-03
K102209 ENCODE PATIENT SPECIFIC ABUTMENT Biomet 3i, Inc. NHA Class II 2010-12-03
K100785 BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES Bonart Co., Ltd. EBW Class I 2010-12-03
K102812 GAMMA-BSM; BETA-BSM; EQUIVABONE Etex Corporation LYC Class II 2010-12-03
K102305 HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P Hass Corp. EIH Class II 2010-12-03
K102382 SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT Cendres & Metaux SA NHA Class II 2010-12-03
K102867 IROOT FS Innovative Bioceramix, Inc. KIF Class II 2010-12-03
K102654 VERTEX RAPID SIMPLIFIED Vertex-Dental B.V. EBI Class II 2010-12-03
K102404 PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) Ventus Medical, Inc. OHP Class II 2010-12-02
K102234 A-DEC 200 DENTAL SYSTEM A-Dec, Inc. EIA Class I 2010-11-24
K102207 FIBER FORCE Synca Marketing, Inc. EBI Class II 2010-11-23
K102254 DMP SINGLE BONDING Dmp, Ltd. KLE Class II 2010-11-23
K102255 DMP ETCHING GEL Dmp, Ltd. EBF Class II 2010-11-23
K102308 SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS Dentium Co., Ltd. DZE Class II 2010-11-22
K101755 AIDI DENTAL IMPLANT SYSTEM Aidi Biomedical, LLC DZE Class II 2010-11-22
K102015 OSTEON, OSTEON SINUS, OSTEON LIFTING Genoss Co., Ltd. LYC Class II 2010-11-19
K102257 NANOCERAM- BRIGHT Dmp, Ltd. EBF Class II 2010-11-19
K100185 SLEEP APP Sleep Medicine Network, Inc. LRK Class II 2010-11-19
K102612 VOCO IONOFIL MOLAR AC QUICK Voco GmbH EMA Class II 2010-11-19
K102083 VELSCOPE VX Led Dental, Inc. NXV Class II 2010-11-18
K102531 MUCOGRAFT Ed. Geistlich Soehne AG Fur Chemische Industrie NPL Class II 2010-11-17
K102603 SA FLOWABLE ADHESIVE Dmg USA, Inc. EBF Class II 2010-11-17
K100100 DIO STEADY EXTERNAL IMPLANT SYSTEM Dio Corporation DZE Class II 2010-11-10
K103164 VONFLEX HEAVY, VINFLEX LIGHT Vericom Co., Ltd. ELW Class II 2010-11-10
K101582 CAM STRUCTSURE BARS Biomet 3i, Inc. NHA Class II 2010-11-08
K102354 GRANDIO SO HEAVY FLOW Voco GmbH EBF Class II 2010-11-08
K102351 GRANDIO SO Voco GmbH EBF Class II 2010-11-02
K102844 ALL-BOUND 3 Bisco, Inc. KLE Class II 2010-10-29
K102575 ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) Do Co., Ltd. KIF Class II 2010-10-29
K101540 GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE Novocol Inc. Dba Septodont and Confi-Dental Produc EBF Class II 2010-10-29
K102347 GRANDTEC Voco GmbH EBI Class II 2010-10-29
K101504 TI-CORE FLOW Essential Dental Systems, Inc. EMA Class II 2010-10-29
K101545 GENESIS IMPLANT SYSTEM Keystone Dental DZE Class II 2010-10-28
K102538 ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI Jyoti Ceramic Industries Private Limited EIH Class II 2010-10-27
K103121 ECO-S Vericom Co., Ltd. EBC Class II 2010-10-26
K101951 LIGHT CURE RETAINER Reliance Orthodontic Products, Inc. DYH Class II 2010-10-26
K101718 OSSEOCONDUCT Steiner Laboratories Div of Steiner Healthcare, LLC LYC Class II 2010-10-26
K102124 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. MUH Class II 2010-10-22
K100212 DENTACENTER/EXPEDITION, MODEL SAF-430 Safari Dental, Inc. EIA Class I 2010-10-22
K102526 BLO2X OXYGEN BLOCKER Pascal Co., Inc. EBF Class II 2010-10-22
K100152 SIRONA CAD/CAM SYSTEM Sirona Dental Systems GmbH NHA Class II 2010-10-22
K100248 DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S Drfp , Ltd. KIF Class II 2010-10-22
K101014 BOND BONE Mis Implants Technologies , Ltd. LYC Class II 2010-10-21
K100960 WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS Cefla Dental Group MUH Class II 2010-10-21
K100172 TOKUYAMA SHIELD FORCE Tokuyama Dental Corporation LBH Class II 2010-10-21
K101104 REMIN PRO Voco GmbH EJR Class I 2010-10-21
K093105 VISTEO Owandy EHD Class II 2010-10-18
K102163 REALSEAL XT SEALER Kerr Corporation KIF Class II 2010-10-16
K093562 ENDOSSEOUS DENTAL IMPLANT Southern Implants, Inc. DZE Class II 2010-10-14
K102450 IONOLUX PRO Voco GmbH EBF Class II 2010-10-08
K101787 DUOLINK II Bisco, Inc. EMA Class II 2010-10-08
K101096 HT III SA FIXTURE SYSTEM Hiossen, Inc. DZE Class II 2010-10-08
K100653 JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD Lang Dental Mfg. Co., Inc. EBI Class II 2010-10-08
K093683 ORTHOPANTOMOGRAPH OP300 Instrumentarium Dental, Palodex Group OY MUH Class II 2010-10-06
K100356 TDS PRECISION DENTAL BAR Pou YU Biotechnology Co., Ltd. NHA Class II 2010-10-05
K101849 BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT Bicon, LLC DZE Class II 2010-10-01
K101880 TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT Zimmer Dental, Inc. DZE Class II 2010-10-01
K101869 PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) Silmet , Ltd. EMA Class II 2010-09-29
K101710 LUXATEMP ULTRA /STAR Dmg USA, Inc. EBG Class II 2010-09-28
K091618 VITOMATRIX Orthovita, Inc. LYC Class II 2010-09-27
K101814 DIRECT CROWN NATURAL 1 Candulor USA, Inc. EBG Class II 2010-09-27
K100540 ASCENT F-COAT MODEL: 006-00097 CAO Group, Inc. LBH Class II 2010-09-23
K101771 RELINE-IT MODEL RELINE-IT Majestic Drug Co., Inc. EBP Class II 2010-09-20
K101420 GC FUJI TEMP GC America, Inc. EMA Class II 2010-09-17
K101245 ULTRASEAL ID Ultradent Products, Inc. EBC Class II 2010-09-17
K101661 MYRAY HYPERION Cefla Dental Group MUH Class II 2010-09-16
K101426 CEROS TCP GRANULES Mathys, Ltd. LYC Class II 2010-09-15
K101064 BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P Bredent GmbH & Co. KG ELM Class II 2010-09-14
K101977 TAPERED SCREW-VENT T IMPLANT Zimmer Dental, Inc. DZE Class II 2010-09-14
K101676 CLEARARCH Ormco Corp. DYW Class II 2010-09-13
K101551 PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M Delma Medical Instrument (Guangzhou) Co., Ltd. EFB Class I 2010-09-09
K100985 BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK BioHorizons Implant Systems, Inc. NHA Class II 2010-09-09
K102118 SNORE GUARD ADVANCE Ranir, LLC LRK Class II 2010-09-08
K093723 EMS MINIMASTER LED E.M.S Electro Medical Systems S.A ELC Class II 2010-09-08
K101617 FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL Heraeus Kulzer, LLC ELW Class II 2010-09-07
K101714 NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS Nobel Biocare AB NHA Class II 2010-08-31
K093821 FS ALIGNER Allesee Orthodontic Appliances NXC Class II 2010-08-27
K101485 ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E Bisco, Inc. KLE Class II 2010-08-26
K082800 STAR/VENT INTERNAL HEX SCREW IMPLANT Park Dental Research Corp. DZE Class II 2010-08-26
K101603 BEAUTIFIL FLOW PLUS Shofu Dental Corp. EBF Class II 2010-08-23
K101875 BK BLANK MODEL 20,40,65,90 Bk Medent Co., Ltd. EIH Class II 2010-08-23
K101621 LITE ART Shofu Dental Corp. EBF Class II 2010-08-23
K101068 ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS Radiant Express, LLC NHA Class II 2010-08-23
K101717 DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING Aerobine, Inc. EFB Class I 2010-08-20
K100512 NOBELPROCERA IPS E.MAX CROWN Nobel Biocare AB EIH Class II 2010-08-20
K101213 GRANDIO FLOW Voco GmbH EBF Class II 2010-08-19
K101493 ADVANCED GLASS IONOMER (K-130) RESTORATIVE Dentsply International, Inc. EMA Class II 2010-08-19
K101798 SPI VARIOMULTI ANGLED ABUTMENT Thommen Medical AG NHA Class II 2010-08-19
K091424 OSTA MAXIGRO AND REGIGRO Osta Technologies NPM Class II 2010-08-18
K101709 LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) Steven B. Lamberg, Dds LRK Class II 2010-08-18

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