Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2016-11-28
Clearances · page 24 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | DYW | Class II | 2016-11-28 |
| K163207 | Filtek One Bulk Fill Restorative | 3M Company | EBF | Class II | 2016-11-28 |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | EBW | Class I | 2016-11-23 |
| K161435 | Temporary Snap Abutment | Nobel Biocare AB | NHA | Class II | 2016-11-22 |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | ELL | Class II | 2016-11-22 |
| K161891 | HC Primer | Shofu Dental Corporation | KLE | Class II | 2016-11-21 |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC | Hager& Meisinger GmbH | NHA | Class II | 2016-11-21 |
| K160786 | RODO Abutment System | Rodo Medical, Inc. | NHA | Class II | 2016-11-21 |
| K160800 | DuoCem | Coltene/Whaledent AG | EMA | Class II | 2016-11-16 |
| K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | EBF | Class II | 2016-11-16 |
| K160049 | Charisma | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | EBF | Class II | 2016-11-15 |
| K160079 | rainbow Shine | Genoss Co., Ltd. | EIH | Class II | 2016-11-10 |
| K152660 | HYPNOSPAD | Somnics, Inc. | LRK | Class II | 2016-11-09 |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | PLC | Class II | 2016-11-07 |
| K162257 | P1145 Dental Restorative | Kerr Corporation | EBF | Class II | 2016-11-07 |
| K162585 | SuniIQ Digital Radiography System | Suni Medical Imaging, Inc. | MUH | Class II | 2016-11-04 |
| K162619 | I View and Imagen Sensor | Trident S.R.L | MUH | Class II | 2016-11-04 |
| K160979 | Inclusive Abutments | Prismatik Dentalcraft, Inc. | NHA | Class II | 2016-11-04 |
| K161131 | FONA Pan/Ceph | Fona S.R.L | MUH | Class II | 2016-11-03 |
| K152615 | Vonflex S | Vericom Co., Ltd. | ELW | Class II | 2016-11-03 |
| K161851 | Glass Ionomer Cement (Luting) | Shandong Huge Dental Material Corporation | EMA | Class II | 2016-10-31 |
| K160519 | Link Abutment for CEREC | Osstem Implant Co., Ltd. | NHA | Class II | 2016-10-28 |
| K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | DZE | Class II | 2016-10-28 |
| K153332 | ETIII SA Fixture System (O3.2mm) | Hiossen, Inc. | DZE | Class II | 2016-10-27 |
| K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | Kuraray Noritake Dental, Inc. | KLE | Class II | 2016-10-25 |
| K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Schutz Dental GmbH | EBF | Class II | 2016-10-24 |
| K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | DZE | Class II | 2016-10-21 |
| K160363 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | JEY | Class II | 2016-10-20 |
| K160203 | ADAMANT ZIRCONIA DISC | Adamant Co., Ltd. | EIH | Class II | 2016-10-19 |
| K161580 | Premier Sealant | Premier Dental Company Products | EBC | Class II | 2016-10-18 |
| K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | DZE | Class II | 2016-10-17 |
| K160782 | BracePaste Adhesive | American Orthodontics | DYH | Class II | 2016-10-14 |
| K153521 | IH Implant System | Sewonmedix, Inc. | DZE | Class II | 2016-10-14 |
| K161677 | Straumann Sterile Healing Solution | Institut Straumann AG | NHA | Class II | 2016-10-07 |
| K161684 | Quantum LB | Reliance Orthodontic Products, Inc. | DYH | Class II | 2016-10-06 |
| K161330 | Pour Acrylic | Dentsply Sirona | EBI | Class II | 2016-10-06 |
| K160060 | DMi Dental Implant System | Dmi Innovative Medical Technology , Ltd. | DZE | Class II | 2016-10-03 |
| K160443 | TempoCem Clear | Dmg USA, Inc. | EMA | Class II | 2016-09-30 |
| K161774 | i-Sil | Spident Co., Ltd. | ELW | Class II | 2016-09-30 |
| K160410 | WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head | Dental Savings Club | EFB | Class I | 2016-09-29 |
| K160436 | CreoDent Solidex Custom Abutment | Creodent Prosthetics, Ltd. | NHA | Class II | 2016-09-29 |
| K153546 | PINK CAD/CAM disc | Polident D.O.O., Dental Products Industry | EBI | Class II | 2016-09-28 |
| K160957 | CDB Self Ligating Bracket 8F | Cdb Corporation | NJM | Class II | 2016-09-27 |
| K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona | EKX | Class I | 2016-09-27 |
| K162107 | TPH Spectra+ Universal Composite Restorative | Dentsply Sirona | EBF | Class II | 2016-09-27 |
| K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | LRK | Class II | 2016-09-23 |
| K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | NHA | Class II | 2016-09-21 |
| K162306 | SomnoDent ALPHA | Somnomed, Inc. | LRK | Class II | 2016-09-20 |
| K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | Institut Straumann AG | EIH | Class II | 2016-09-16 |
| K160964 | Neodent Implant System - Titanium Base for CEREC | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2016-09-16 |
| K152023 | Luminesse Shaded Zirconia SZ | Talladium, Inc. | EIH | Class II | 2016-09-15 |
| K161630 | Provicol QM Plus | Voco GmbH | EMB | Class I | 2016-09-15 |
| K160828 | Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. | NHA | Class II | 2016-09-15 |
| K160784 | CAM Titanium Blanks | Altatec GmbH | NHA | Class II | 2016-09-14 |
| K153676 | OSTEON III | Genoss Co., Ltd. | LYC | Class II | 2016-09-14 |
| K153130 | Initial LiSi Block | GC America, Inc. | EIH | Class II | 2016-09-13 |
| K160867 | Pavati Z40.2 Zirconia | Ccri, Inc. | EIH | Class II | 2016-09-12 |
| K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | DZE | Class II | 2016-09-12 |
| K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | KLE | Class II | 2016-09-09 |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Salvin Dental Specialties | NPK | Class II | 2016-09-08 |
| K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | DZE | Class II | 2016-09-08 |
| K161406 | Navident | Claronav, Inc. | PLV | Class II | 2016-09-08 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | PNP | Class II | 2016-09-06 |
| K152981 | JET SET 4 DENTURE REPAIR RESIN | Lang Dental Manufacturing Company, Inc. | EBI | Class II | 2016-09-02 |
| K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | EHD | Class II | 2016-09-01 |
| K160531 | Noiselezz | Firma Ingemarsson | LRK | Class II | 2016-09-01 |
| K161239 | MTA2.2 MATERIAL | Avalon Biomed, Inc. | KIF | Class II | 2016-09-01 |
| K161922 | XP202 | 3M Deutschland GmbH | EIH | Class II | 2016-09-01 |
| K151047 | MTA Repair HP | Angelus Industria DE Productos Odontologicos | KIF | Class II | 2016-08-31 |
| K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | NHA | Class II | 2016-08-29 |
| K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | DYW | Class II | 2016-08-26 |
| K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Tomy, Inc. | NJM | Class II | 2016-08-26 |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | DZE | Class II | 2016-08-26 |
| K161030 | ATLANTIS Abutment for CONELOG implant | Dentsply Sirona | NHA | Class II | 2016-08-26 |
| K153509 | GPS Angled Abutment | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2016-08-26 |
| K153476 | KATANA AVENCIA Block | Kuraray Noritake Dental, Inc. | EBF | Class II | 2016-08-23 |
| K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | EBZ | Class II | 2016-08-22 |
| K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | DZI | Class II | 2016-08-15 |
| K161269 | CELTRA Press | Dentsply Sirona | EIH | Class II | 2016-08-12 |
| K153285 | EMS-200 | Meta Systems Co., Ltd. | EKX | Class I | 2016-08-12 |
| K160382 | OT EQUATOR | Rhein'83 Srl | NHA | Class II | 2016-08-11 |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | PLC | Class II | 2016-08-10 |
| K153200 | SnoreRx | Apnea Sciences Corporation | LRK | Class II | 2016-08-09 |
| K160483 | Burn-out Cylinder and Angled Screw Abutments | Dentium Co., Ltd. | NHA | Class II | 2016-08-05 |
| K160097 | Image Fast Set, Image Regular Set | Sybron Dental Specialties | ELW | Class II | 2016-08-05 |
| K160248 | ArgenIS Titanium Abutments | Argen Corporation | NHA | Class II | 2016-08-05 |
| K160281 | OSSIX PLUS | Datum Dental, Ltd. | NPL | Class II | 2016-08-04 |
| K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | NPL | Class II | 2016-08-04 |
| K152471 | CAPO BULK FILL | Schuetz Dental GmbH | EBF | Class II | 2016-08-04 |
| K160774 | IonoStar Plus | Voco GmbH | EMA | Class II | 2016-08-03 |
| K151542 | A-Oss | Hiossen, Inc. | NPM | Class II | 2016-08-03 |
| K151757 | IMMEDIATELOAD Dental Implant System | Immediateload S.A. | DZE | Class II | 2016-08-03 |
| K153493 | Clip Flow | Voco GmbH | EBF | Class II | 2016-07-29 |
| K161256 | TheraCem | Bisco, Inc. | EMA | Class II | 2016-07-29 |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | Sybron Dental Specialties | KIF | Class II | 2016-07-27 |
| K160596 | BEAUTIFIL II LS | Shofu Dental Corporation | EBF | Class II | 2016-07-27 |
| K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | DZE | Class II | 2016-07-27 |
| K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nissin-Metec China Co., Ltd. | EIH | Class II | 2016-07-27 |
| K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | Nobel Biocare AB | NHA | Class II | 2016-07-25 |
| K152787 | ST Internal Fixture System | T-Plus Implant Tech. Co., Ltd. | DZE | Class II | 2016-07-22 |
12,679 clearances in the Dental panel. Data: openFDA.