meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
2005-10-03

Clearances · page 52 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051872 MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 Mk-Dent GmbH EFB Class I 2005-10-03
K052593 FUSION CURING LIGHT Dentlight, Inc. EBZ Class II 2005-09-28
K052235 LCR 3M Company EMA Class II 2005-09-27
K052422 THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) Flow X-Ray Corp. EAP Class II 2005-09-27
K051859 SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM Sin Sistema DE Implante Nacional Ltda DZE Class II 2005-09-23
K052245 ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS Lar Mfg., LLC NJM Class II 2005-09-23
K052419 MAXIMUS 3.0 AND OS IMPLANTS BioHorizons Implant Systems, Inc. DZE Class II 2005-09-20
K051782 BLUEPHASE 16I Ivoclar Vivadent, Inc. EBZ Class II 2005-09-20
K052444 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd. JEY Class II 2005-09-20
K051552 O.A.S.I. SYSTEM Lancer Orthodontics, Inc. DZE Class II 2005-09-19
K051750 FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 Ultradent Products, Inc. LBH Class II 2005-09-19
K051885 MBCP Biomatlante LYC Class II 2005-09-16
K051461 3I OSSEOTITE DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2005-09-15
K051614 PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS Lifecore Biomedical, Inc. DZE Class II 2005-09-09
K051952 EUGENONE Scientific Pharmaceuticals, Inc. EMA Class II 2005-09-07
K051866 PREMIER TEMPORARY CEMENT Premier Dental Products Co. EMA Class II 2005-09-06
K051661 IMPLANT HANDPIECES Sirona Dental Systems GmbH EKX Class I 2005-09-06
K051910 MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER D.B.I. America Corp. ELC Class II 2005-09-02
K051507 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC DZE Class II 2005-09-02
K052334 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 Dentsply Intl. ELC Class II 2005-09-02
K051018 INTERMEZZO IMPLANT SYSTEMS Megagen Co., Ltd. DZE Class II 2005-09-02
K051576 AVANA DENTAL IMPLANT SYSTEM Osstem Co., Ltd. DZE Class II 2005-09-01
K051091 SYNTHOGRAFT Bicon, Inc. LYC Class II 2005-09-01
K051657 A-DEC SELF-CONTAINED WATER SYSTEM A-Dec, Inc. EIA Class I 2005-08-30
K050170 FORTOSS VITAL BONE GRAFT SUBSTITUTE Biocomposites, Ltd. LYC Class II 2005-08-26
K051236 RESORB-X SF KLS-Martin L.P. JEY Class II 2005-08-22
K051946 MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM Medartis, Inc. MQN Class II 2005-08-22
K051427 GC FUJI FIL LC GC America, Inc. EMA Class II 2005-08-22
K051999 BISCOVER LED Bisco, Inc. EBD Class II 2005-08-22
K052130 VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 Vident EIH Class II 2005-08-15
K052097 CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE Dentsply International EBF Class II 2005-08-12
K050984 BIOPLANT Kerr Dental Materials Center LYC Class II 2005-08-11
K050446 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE Ed. Geistlich Soehne AG Fuer Chemische Industrie NPL Class II 2005-08-09
K051014 SILENT PARTNER SERIES OSA APPLIANCES Dreamwrx Dental Laboratory LRK Class II 2005-08-09
K051796 CLEARFIL TRI-S BOND SINGLE DOSE Kuraray Medical Kurashiki Plant KLE Class II 2005-08-09
K051808 ESTELITE FLOW QUICK Tokuyama Dental Corporation EBF Class II 2005-08-08
K052090 SPLASH! IMPRESSION MATERIAL DEVICE Discus Dental, Inc. ELW Class II 2005-08-05
K043034 OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS Collagen Matrix, Inc. NPM Class II 2005-08-04
K051818 BEAUTIFIL FLOW Shofu Dental Corp. EBF Class II 2005-08-03
K042394 DIAGNODENT PERIO TIP (ACCESSORY) Kavo America Corporation NBL Class II 2005-08-02
K043573 DYNAGRAFT II DENTAL Isotis Orthobiologics, Inc. NUN Class II 2005-07-29
K051780 JETLITE 5000 J. Morita USA, Inc. EBZ Class II 2005-07-28
K051527 SPI EASY TEMPORARY CAP Thommen Medical AG NHA Class II 2005-07-28
K050635 ALLFIM IMPLANT SYSTEMS Cowellmedi Co., Ltd. DZE Class II 2005-07-28
K051224 BOSWORTH SEAL Harry J. Bosworth Co. EBC Class II 2005-07-28
K051867 GRANDIO Voco GmbH EBF Class II 2005-07-27
K051868 GRANDIO FLOW Voco GmbH EBF Class II 2005-07-27
K051845 THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM Bioplate, Inc. JEY Class II 2005-07-27
K051652 ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT Atlantis Components, Inc. NHA Class II 2005-07-22
K051751 EQUA-PULL SAFETY RELEASE MODULE Ortho Technology DZB Class II 2005-07-22
K051443 CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO Curasan Ag, Frankfurt Facility LYC Class II 2005-07-22
K051249 ZIROX Wieland Dental + Technik GmbH & Co. KG EIH Class II 2005-07-22
K051797 FUTURE WASH/YPS 3M Espe AG Dental Products ELW Class II 2005-07-21
K043322 MIRAMATIC SAFE SYRINGE SYSTEM Hager Worldwide, Inc. EJI Class II 2005-07-21
K051664 SCAN300FP / RETROPAN (VDC) Oy Ajat, Ltd. MUH Class II 2005-07-20
K042583 CALC-I-OSS Ultradent Products, Inc. LYC Class II 2005-07-19
K051571 SKYLIGHT LED CURING LIGHT Dmetec.Co., Ltd. EBZ Class II 2005-07-19
K050417 ELITE IMPLANT Zhermack S.P.A. ELW Class II 2005-07-19
K051545 L.E. DEMETRON II Kerr Corporation (Danbury) EBZ Class II 2005-07-18
K051424 HYDROGUM 5 Zhermack S.P.A. ELW Class II 2005-07-15
K051381 ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE Ace Surgical Supply Co., Inc. LYC Class II 2005-07-15
K051707 ECLIPSE BONDING AGENT Dentsply Intl. KLE Class II 2005-07-15
K050260 BIORESORB MACRO PORE Oraltronics Dental Implant Technology GmbH LYC Class II 2005-07-15
K051795 NOMAD DENTAL X-RAY SYSTEM Aribex, Inc. EHD Class II 2005-07-14
K051547 POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 Tpc Advanced Technology, Inc. ELC Class II 2005-07-14
K051776 PROTEGE ULTRASONIC INSERT Discus Dental, Inc. ELC Class II 2005-07-13
K043428 RELIADENT DENTAL IMPLANT SYSTEM Bioinfera, Inc. NHA Class II 2005-07-12
K051463 XENO ADHESIVE WITH ACTIVATOR Dentsply Intl. KLE Class II 2005-07-12
K050592 SOMNOMED MAS RXA Somnomed, Ltd. LRK Class II 2005-07-12
K051011 ENDOSSEOUS DENTAL IMPLANT ABUTMENT Atlantis Components, Inc. NHA Class II 2005-07-12
K050444 NOBELREPLACE ADAPTER, MODEL 32412 Nobel Biocare Uas, Inc. NHA Class II 2005-07-07
K051717 RN SYNOCTA TEMPORARY MESO ABUTMENT Institut Straumann SA NHA Class II 2005-07-07
K051358 NATURE-CRYL HI PLUS GC America, Inc. EBI Class II 2005-07-07
K051050 SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 Schutz-Dental GmbH KLE Class II 2005-06-29
K051535 MODIFICATION TO:REGISTRADO X-TRA Voco GmbH ELW Class II 2005-06-28
K051462 MODIFICATION TO: CERCON BASE Dentsply Intl. EIH Class II 2005-06-24
K051464 PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) Planmeca Oy EHD Class II 2005-06-24
K050903 XAWEX G 100 Wieland Dental + Technik GmbH & Co. KG EIH Class II 2005-06-23
K051243 JET BLUE BITE Coltene/Whaledent AG ELW Class II 2005-06-23
K051207 CAVEX ORTHOTRACE Cavex Holland BV ELW Class II 2005-06-21
K051502 SPI DENTAL IMPLANT Thommen Medical AG DZE Class II 2005-06-21
K051008 SET Southern Dental Industries, Ltd. EMA Class II 2005-06-15
K050478 MEDICON IMF-ORION SCREWS Medicon EG DZE Class II 2005-06-15
K051267 GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE W. L. Gore & Associates, Inc. NPK Class II 2005-06-15
K050208 FRIADENT ESTHETICAP Dentsply International NHA Class II 2005-06-14
K051293 CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM Ceremed , Inc. JEY Class II 2005-06-14
K050871 RIVA PROTECT Southern Dental Industries, Inc. EBC Class II 2005-06-10
K051189 PREVAIL DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2005-06-08
K050406 NOBELSPEEDY IMPLANTS Nobel Biocare AB DZE Class II 2005-06-08
K043408 PIEZOSURGERY DEVICE Piezosurgery S.R.L. DZI Class II 2005-06-08
K050486 PROTECT TOOTH DESENSITIZER Sunstar Butler LBH Class II 2005-06-07
K051006 IBOND NEXT GENERATION Heraeus Kulzer,GmbH KLE Class II 2005-06-07
K050870 RIVA LIGHT CURE Southern Dental Industries, Inc. EMA Class II 2005-06-03
K050568 ORLUS MINI SCREW Ortholution Co., Ltd. DZE Class II 2005-06-01
K051341 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 Inion , Ltd. JEY Class II 2005-05-27
K050658 RESO-PAC PERIODONTAL DRESSING Hager Worldwide, Inc. EMA Class II 2005-05-27
K050693 ACCENT Air Techniques, Inc. MUH Class II 2005-05-26
K050669 JEIL BONE FIXATION SYSTEM Jeil Medical Corporation JEY Class II 2005-05-26
K051203 BLUELEX Monitex Industrial Co., Ltd. EBZ Class II 2005-05-25
K050735 MC6A Macan Engineering Co. EKZ Class II 2005-05-23

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