Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2008-08-21
Clearances · page 44 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K081393 | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | G & H Wire Co. | OAT | Class II | 2008-08-21 |
| K081405 | XERACEM | Doxa Dental AB | EMA | Class II | 2008-08-21 |
| K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | Megagen Implant Co., Ltd. | DZE | Class II | 2008-08-15 |
| K081695 | DMC COMPOSITE | Kerr Corp. | EBF | Class II | 2008-08-12 |
| K081200 | DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 | Global Top, Inc. | EIH | Class II | 2008-08-08 |
| K073047 | APROXI 1100 AND 4000 SERIES DENTAL INLAYS | Aproxi Aps | EBF | Class II | 2008-08-07 |
| K081191 | TCM ENDO 20 | NOUVAG AG | EKX | Class I | 2008-08-07 |
| K082157 | KETTOSIL AND SILGINAT | Kettenbach GmbH & Co. KG | ELW | Class II | 2008-08-06 |
| K081721 | TRICOS A RESORBABLE SUBSTITUTE | Baxter Healthcare Corp | LYC | Class II | 2008-08-06 |
| K080749 | RADIANCE | American Orthodontics | NJM | Class II | 2008-08-04 |
| K081017 | TEMPLATE AND COUNTER-FIT | Clinician'S Choice Dental Products, Inc. | ELW | Class II | 2008-08-04 |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW | Class II | 2008-07-29 |
| K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | Italia Medica S.R.L. | DZI | Class II | 2008-07-28 |
| K081561 | OSFERION D | Olympus Terumo Biomaterials Corporation | LYC | Class II | 2008-07-28 |
| K081583 | CLEARFIL SA CEMENT | Kuraray Medical, Inc. | EMA | Class II | 2008-07-28 |
| K080814 | VOCO PROFLUORID VARNISH | Voco GmbH | LBH | Class II | 2008-07-24 |
| K081157 | ACCUFRAME | Cagenix, Inc. | NHA | Class II | 2008-07-22 |
| K080864 | CAM STRUCTSURE PRECISION MILLED BARS | Biomet 3i, Inc. | NHA | Class II | 2008-07-21 |
| K080862 | SONICWELD RX (RESORB-X) | KLS-Martin L.P. | JEY | Class II | 2008-07-21 |
| K081950 | PROGENIX PLUS | Medtronic Sofamor Danek, Inc. | NUN | Class II | 2008-07-18 |
| K080744 | HG II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-07-17 |
| K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | Classone Orthodontics, Inc. | DYH | Class II | 2008-07-16 |
| K080633 | SCREWINDIRECT DENTAL IMPLANTS | Implant Direct, LLC | DZE | Class II | 2008-07-15 |
| K081078 | NT/IT SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-07-15 |
| K081273 | ULTRACAPS S | Sdi , Ltd. | OIV | Class II | 2008-07-10 |
| K073678 | VARIOSURG | Nakanishi, Inc. | DZI | Class II | 2008-07-10 |
| K080224 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK | SOADCO, S.L. | DZE | Class II | 2008-07-03 |
| K081263 | STARCERAM | H.C. Starck Ceramics GmbH & Co.Kg | EIH | Class II | 2008-07-01 |
| K081664 | NOMAD PRO X-RAY SYSTEM | Aribex, Inc. | EHD | Class II | 2008-06-23 |
| K080687 | SMARTBURS | S.S. White Burs, Inc. | EJL | Class I | 2008-06-20 |
| K080940 | ESTELITE SIGMA QUICK | Tokuyama Dental Corporation | EBF | Class II | 2008-06-19 |
| K072731 | ENDSNOR | Dockstader Orthodontic Lab, Inc. | LRK | Class II | 2008-06-12 |
| K080517 | RESICEM | Shofu Dental Corp. | EMA | Class II | 2008-06-11 |
| K080724 | GC OPB-100 | GC America, Inc. | DYH | Class II | 2008-06-11 |
| K080834 | VINTAGE ART | Shofu Dental Corp. | EIH | Class II | 2008-06-11 |
| K080146 | ZIRKONDENT | Ergometa | EIH | Class II | 2008-06-06 |
| K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | Kaltenbach & Voigt GmbH & Co. | EIA | Class I | 2008-06-06 |
| K080478 | GRADIA FORTE | GC America, Inc. | EBF | Class II | 2008-06-05 |
| K080772 | BONEMEDIK-DM | Meta Biomed Co., Ltd. | LYC | Class II | 2008-06-03 |
| K080129 | SECURE IMPLANT SYSTEM (2.5/3.0MM) | Dio Department Dsi, Inc. | DZE | Class II | 2008-05-30 |
| K080115 | I-MINI DENTAL IMPLANT | Oco Biomedical | DZE | Class II | 2008-05-30 |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | Dmg USA, Inc. | EBF | Class II | 2008-05-30 |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPL | Class II | 2008-05-30 |
| K081186 | CONCAVE RN HEALING CAP | Institut Straumann AG | NHA | Class II | 2008-05-23 |
| K080631 | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | Oral Health Technologies, LLC | EFT | Class I | 2008-05-23 |
| K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | Dentsply Interntional | DYH | Class II | 2008-05-22 |
| K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | Intra-Lock International | NHA | Class II | 2008-05-21 |
| K080479 | DENTAL CERAMIC | Dmg USA, Inc. | EIH | Class II | 2008-05-21 |
| K080713 | REACTIVE DENTAL IMPLANT SYSTEM | Implant Direct, LLC | DZE | Class II | 2008-05-16 |
| K073070 | DIO BIOTITE-H IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2008-05-16 |
| K081253 | ZIRDENT CAD/CAM BLOCKS | C5 Medical Werks, Inc. | EIH | Class II | 2008-05-15 |
| K080694 | OSTEOMED MODULAR LOCKING FIXATION SYSTEM | Osteomed LP | JEY | Class II | 2008-05-15 |
| K073217 | INCLUSIVE IMPLANT ABUTMENTS | Inclusive Dental Solutions | NHA | Class II | 2008-05-14 |
| K080128 | SM-EXTRA WIDE (RBM) IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2008-05-14 |
| K081084 | COLORISE RIGID | Zhermack S.P.A. | ELW | Class II | 2008-05-14 |
| K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) | MQN | Class II | 2008-05-14 |
| K073622 | EASY GRIP DENTAL IMPLANT SYSTEM | T.F.I. System S.R.L | DZE | Class II | 2008-05-14 |
| K080462 | PROGENIX DBM PUTTY | Medtronic Sofamor Danek | NUN | Class II | 2008-05-13 |
| K080738 | DENTRON SENSOR | Dentron Systems, LLC | EAP | Class II | 2008-05-13 |
| K080549 | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | EBD | Class II | 2008-05-13 |
| K073097 | TUTODENT DENTAL MEMBRANE | Tutogen Medical U.S., Inc. | NPL | Class II | 2008-05-12 |
| K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | Biomet Microfixation, Inc. | JEY | Class II | 2008-05-09 |
| K072595 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | DZE | Class II | 2008-05-09 |
| K080397 | AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM | American Dental Implant Corporation | NHA | Class II | 2008-05-06 |
| K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS | Institut Straumann AG | NHA | Class II | 2008-05-02 |
| K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES | Merz Dental GmbH | EBG | Class II | 2008-05-02 |
| K081143 | BIOMERS TRANSLUCENT ORTHODONTIC WIRE | Biomers Product, LLC | DYW | Class II | 2008-05-02 |
| K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | Kettenbach GmbH & Co. KG | ELW | Class II | 2008-05-01 |
| K080239 | P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS | Straumann Manufacturing, Inc. | NHA | Class II | 2008-04-30 |
| K080331 | SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM | Synthes (Usa) | JEY | Class II | 2008-04-30 |
| K080396 | OSSEOSPEED NARROW | Astra Tech AB | DZE | Class II | 2008-04-30 |
| K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. | NUN | Class II | 2008-04-30 |
| K080889 | KODAK 9000C EXTRAORAL IMAGING SYSTEM | Trophy | MUH | Class II | 2008-04-29 |
| K080195 | NACERA Z AND NACERA Z MEDIUM | Doceram Medical Ceramics GmbH | EIH | Class II | 2008-04-28 |
| K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | Mis Implants Technologies , Ltd. | DZE | Class II | 2008-04-22 |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | Heraeus Kulzer,GmbH | ELW | Class II | 2008-04-21 |
| K071447 | VARIOS 75 | Nakanishi, Inc. | ELC | Class II | 2008-04-18 |
| K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | Dentsply Interntional | EBG | Class II | 2008-04-18 |
| K070570 | DIO IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2008-04-15 |
| K080308 | BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD | Bioscaffold International Pte, Ltd. | LYC | Class II | 2008-04-14 |
| K080126 | DIO PROTEM IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE | Class II | 2008-04-11 |
| K080882 | CEREC OPTI SPRAY | Sirona Dental Systems GmbH | ELW | Class II | 2008-04-11 |
| K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET | Ultradent Products, Inc. | EMA | Class II | 2008-04-11 |
| K073106 | UNIFAST III | GC America, Inc. | EBG | Class II | 2008-04-11 |
| K080246 | COMPOSITE ALIGNER BUTTON | Dentsply Interntional | NXC | Class II | 2008-04-11 |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE | Class II | 2008-04-11 |
| K080917 | IROOT SP | Innovative Bioceramix, Inc. | KIF | Class II | 2008-04-09 |
| K073571 | TRICOS T RESORBABLE BONE SUBSTITUTE | Baxter Healthcare Corporation | LYC | Class II | 2008-04-08 |
| K073365 | DENTAL DIGITAL X-RAY IMAGING SYSTEM | VATECH Co., Ltd. | MUH | Class II | 2008-04-08 |
| K073696 | VERAVIEWEPOCS | J. Morita USA, Inc. | MUH | Class II | 2008-04-08 |
| K080182 | ZENO PMMA DISC | Wieland Dental + Technik GmbH & Co. KG | EBG | Class II | 2008-04-08 |
| K073465 | US/GS ULTRA WIDE SYSTEM | Osstem Implant Co., Ltd. | DZE | Class II | 2008-04-07 |
| K080305 | NEXCOMP AND META ETCHANT | Meta Biomed Co., Ltd. | EBF | Class II | 2008-04-07 |
| K073486 | DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | DZE | Class II | 2008-04-04 |
| K073458 | BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) | Btlock Srl | DZE | Class II | 2008-04-04 |
| K080438 | DENTAL UNIT WITH CHAIR | North West Medical Instrument (Group) Co., Ltd. | EIA | Class I | 2008-04-04 |
| K080043 | VIZILITE EYEWEAR | Zila, Inc. | NXV | Class II | 2008-04-04 |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Den-Mat Holdings, LLC | NXV | Class II | 2008-04-03 |
| K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS | Dentsply International, Inc. | DZE | Class II | 2008-03-31 |
| K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | Blue Sky Bio, LLC | DZE | Class II | 2008-03-28 |
12,679 clearances in the Dental panel. Data: openFDA.