Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2015-04-14
Clearances · page 28 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | EJK | Class II | 2015-04-14 |
| K143265 | Acrylic Block | Sun Medical Co., Ltd. | EBI | Class II | 2015-04-14 |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | NPK | Class II | 2015-04-13 |
| K143465 | MASTERmatic LUX | Kaltenbach & Voigt GmbH | EFA | Class I | 2015-04-09 |
| K140233 | ULTRASONIC SCALER | Nanning Baolai Medical Instrument Co., Ltd. | ELC | Class II | 2015-04-06 |
| K143575 | Accu-Dent XD Tray, Accu-Dent XD Syringe | Ivoclar Vivadent, Inc. | ELW | Class II | 2015-04-03 |
| K150164 | Monobond Etch & Prime | Ivoclar Vivadent, AG | KLE | Class II | 2015-04-03 |
| K150060 | J2A Dental Implant System, J2C Dental Implant System | Kj Meditech Co., Ltd. | DZE | Class II | 2015-04-02 |
| K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | DZE | Class II | 2015-04-02 |
| K143338 | Argulated Locking Plates | Osteomed LP | JEY | Class II | 2015-04-01 |
| K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | JEY | Class II | 2015-04-01 |
| K142426 | EBI External Implant System | Ebi, Inc. | DZE | Class II | 2015-03-27 |
| K150196 | DD cubeX2 | Dental Direkt GmbH | EIH | Class II | 2015-03-26 |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG | EBF | Class II | 2015-03-25 |
| K140806 | IBS IMPLANT SYSTEM | Innobiosurg Co., Ltd. | DZE | Class II | 2015-03-23 |
| K142174 | BIOMATE DENTAL IMPLANT SYSTEM | Biomate Medical Devices Technology Co., Ltd. | DZE | Class II | 2015-03-20 |
| K143703 | NICAL SMART MICRO CR system for intraoral dental images | Nical Spa | MUH | Class II | 2015-03-18 |
| K142001 | SYNTEC WETALI ORTHODONTIC MINI SCREWS | Syntec Scientific Corporation - Taipei Office | OAT | Class II | 2015-03-18 |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and Primer | Danville Materials, LLC | DYH | Class II | 2015-03-18 |
| K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co., Ltd. | EIA | Class I | 2015-03-13 |
| K141159 | KONUS DENTAL IMPLANT SYSTEM | Argon Med. Productions Vertriebs Gesellschaft Mbh | DZE | Class II | 2015-03-11 |
| K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | Rayence Co., Ltd. | MUH | Class II | 2015-03-10 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | EBC | Class II | 2015-03-09 |
| K143439 | KATANA Zirconia | Kuraray Noritake Dental, Inc. | EIH | Class II | 2015-02-27 |
| K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | ELC | Class II | 2015-02-27 |
| K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | Ttbio Corp. | EFB | Class I | 2015-02-27 |
| K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. | EMA | Class II | 2015-02-26 |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Dentsply International, Inc. | KIF | Class II | 2015-02-26 |
| K141504 | T-8000 THEROZONE UNIT | Therozone USA, Inc. | EIA | Class I | 2015-02-24 |
| K142848 | EAZY PRIMER | Parkell, Inc. | KLE | Class II | 2015-02-24 |
| K143382 | DentiAnn Smart Sil | Seilglobal Co., Ltd. | ELW | Class II | 2015-02-23 |
| K142167 | MEDENTIKA ABUTMENT SYSTEM | Medentika GmbH | NHA | Class II | 2015-02-20 |
| K142358 | Osstell IDx | Osstell AB | EKX | Class I | 2015-02-19 |
| K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters | EFB | Class I | 2015-02-17 |
| K143337 | CONELOG Titanium base CAD/CAM | Altatec GmbH | NHA | Class II | 2015-02-17 |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | DYH | Class II | 2015-02-13 |
| K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | Schutz-Dental GmbH | EBG | Class II | 2015-02-12 |
| K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | EIH | Class II | 2015-02-11 |
| K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | EBG | Class II | 2015-02-09 |
| K143209 | SonicFill 2 | Sybron Dental Specialties | EBF | Class II | 2015-02-05 |
| K142880 | DMRC Light Cure Orthodontic Adhesive System | Daville Materials, LLC | DYH | Class II | 2015-02-04 |
| K142894 | TCS Blend | Thermoplastic Comfort Systems, Inc. | EBI | Class II | 2015-02-03 |
| K142242 | PREMIUM, SHELTA Implant Systems | Sweden & Martina S.P.A. | DZE | Class II | 2015-02-02 |
| K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | LBH | Class II | 2015-01-29 |
| K141400 | DCCERAM SYSTEM | Ceramay GmbH & Co.Kg | EIH | Class II | 2015-01-28 |
| K133733 | WINSIX Implant System | Biosaf IN S.R.L. | DZE | Class II | 2015-01-28 |
| K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) | Kuraray Noritake Dental, Inc. | EMA | Class II | 2015-01-27 |
| K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | Zimmer Dental, Inc. | NHA | Class II | 2015-01-21 |
| K140037 | OPTIMUS CMF SYSTEM | Osteonic Co., Ltd. | JEY | Class II | 2015-01-20 |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit | Straumann USA, LLC | NHA | Class II | 2015-01-09 |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems, Inc. | DZE | Class II | 2015-01-08 |
| K133412 | S200, S300 | Cefla S.C. | EIA | Class I | 2015-01-08 |
| K143486 | Ufi Gel hard C | Voco GmbH | EBI | Class II | 2015-01-07 |
| K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | Sterngold Dental, LLC | DZE | Class II | 2015-01-07 |
| K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X | Prismatik Dentalcraft, Inc. | NHA | Class II | 2015-01-06 |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | 2015-01-05 |
| K133088 | ZX-27 | M&M Dental Studio, Inc. | EJX | Class I | 2015-01-02 |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | EKX | Class I | 2014-12-31 |
| K142407 | Straight Stud Attachment | Sterngold Dental, LLC | NHA | Class II | 2014-12-24 |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | Noris Medical , Ltd. | DZE | Class II | 2014-12-19 |
| K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | Liaoning Upcera Co., Ltd. | EIH | Class II | 2014-12-18 |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Osteomed | JEY | Class II | 2014-12-18 |
| K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA | Jensen Industries, Inc. | EIH | Class II | 2014-12-18 |
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Impladent , Ltd. | JEY | Class II | 2014-12-18 |
| K140848 | LUMINESSE PORCELAIN SYSTEM | Talladium, Inc. | EIH | Class II | 2014-12-17 |
| K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | EIH | Class II | 2014-12-15 |
| K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | LRK | Class II | 2014-12-15 |
| K140663 | THERASNORE | Distar, LLC | LRK | Class II | 2014-12-12 |
| K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | Preventive Technologies, Inc. | LBH | Class II | 2014-12-12 |
| K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | Megagen Implant Co., Ltd. | DZE | Class II | 2014-12-12 |
| K140202 | TRAUSIM DENTAL IMPLANT SYSTEM | Jiangsu Trausim Medical Instrument | DZE | Class II | 2014-12-12 |
| K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Ormco Corp. | NOF | Class II | 2014-12-05 |
| K141092 | MARK3 | Cavex Holland BV | ELW | Class II | 2014-12-04 |
| K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | EBF | Class II | 2014-11-25 |
| K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE | Prismatik Dentalcraft, Inc. | NHA | Class II | 2014-11-25 |
| K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | NPL | Class II | 2014-11-24 |
| K133362 | SGS DENTAL IMPLANT | Sgs International, Ltd. | DZE | Class II | 2014-11-21 |
| K141839 | PREMIER ETCH | Premier Dental Products Co. | KLE | Class II | 2014-11-17 |
| K141994 | BULK FILL FLOWABLE COMPOSITE | Novocol, Inc. | EBF | Class II | 2014-11-14 |
| K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT | Prismatik Dentalcraft, Inc. | NHA | Class II | 2014-11-13 |
| K140934 | HIOSSEN IMPLANT SYSTEM | Hiossen, Inc. | DZE | Class II | 2014-11-12 |
| K140807 | COMPOSITE ORTHODONTIC BRACKETS | Ortho Specialties | DYW | Class II | 2014-11-12 |
| K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS | Dentium Co., Ltd. | NHA | Class II | 2014-11-12 |
| K141503 | DENALI 501CEMENT | Denali Corporation | EMA | Class II | 2014-11-10 |
| K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | Prismatik Dentalcraft, Inc. | EIH | Class II | 2014-11-06 |
| K132230 | ICE ZIRKON TRANSLUZENT | Zirkonzahn Srl | EIH | Class II | 2014-11-05 |
| K133507 | GUIDOSS | Nibec Co., Ltd. | NPL | Class II | 2014-11-05 |
| K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | NPL | Class II | 2014-11-05 |
| K140293 | TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM | Adin Dental Implants Systems , Ltd. | DZE | Class II | 2014-10-31 |
| K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | MUH | Class II | 2014-10-31 |
| K140052 | J2I IMPLANT SYSTEM | Kj Meditech Co., Ltd. | DZE | Class II | 2014-10-30 |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | EJI | Class II | 2014-10-30 |
| K140051 | KJ EXTERNAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | DZE | Class II | 2014-10-30 |
| K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | Zimmer Dental, Inc. | DZE | Class II | 2014-10-28 |
| K142063 | #8C RENEGADE DENTAL HANDPIECE | Handpiece Club, LLC | EFB | Class I | 2014-10-28 |
| K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | Lares Research, Inc. | EFB | Class I | 2014-10-28 |
| K140684 | CLINPRO PROPHY POWDER | 3M Deutschland GmbH | PIP | Class II | 2014-10-24 |
| K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | EFB | Class I | 2014-10-24 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | EGS | Class I | 2014-10-23 |
| K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS | Prismatik Dentalcraft, Inc. | NHA | Class II | 2014-10-22 |
12,679 clearances in the Dental panel. Data: openFDA.