Implant, Endosseous, Root-Form
Regulation 872.3640
19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2013 | K121406 | INCLUSIVE TAPERED IMPLANT SYSTEM Prismatik Dentalcraft, Inc. | DZE |
| Jan 30, 2013 | K122300 | T3 DENTAL IMPLANT Biomet 3i | DZE |
| Jan 17, 2013 | K121098 | HERO I DENTAL IMPLANT SYSTEM Kj Meditech Co., Ltd. | DZE |
| Jan 7, 2013 | K121585 | TS IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Dec 21, 2012 | K120793 | Z-LOOK3 EVO SLM Z-Systems AG | DZE |
| Dec 20, 2012 | K111189 | SYNTEC DENTAL IMPLANT Syntec Scientific Corp., TW | DZE |
| Dec 14, 2012 | K113779 | CONELOG IMPLANT SYSTEM Altatec GmbH | DZE |
| Dec 12, 2012 | K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS Straumann USA | DZE |
| Nov 29, 2012 | K121995 | TS FIXTURE SYSTEM Osstem Implant Co., Ltd. | DZE |
| Nov 28, 2012 | K122052 | MINIFIX BALL MINIFIX ONE Bonafix Surgical and Dental Implants, LLC | DZE |
| Nov 16, 2012 | K122171 | MS SA IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Nov 16, 2012 | K113113 | ENDOSSEOUS DENTAL IMPLANT Ot Medical GmbH, DE | DZE |
| Oct 4, 2012 | K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM Megagen Implant Co., Ltd. | DZE |
| Oct 4, 2012 | K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM Kj Meditech Co., Ltd. | DZE |
| Sep 24, 2012 | K121707 | LEW MDI O-BALL COLLARED IMPLANT, Park Dental Research Corp. | DZE |
| Sep 7, 2012 | K120875 | B&W DENTAL IMPLANT SYSTEM B&W Srl, AR | DZE |
| Sep 5, 2012 | K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Sep 5, 2012 | K120792 | TIXOS IMPLANT SYSTEM Leader Italia S.R.L. | DZE |
| Sep 5, 2012 | K113376 | NEOSS PROACTIVE TAPERED IMPLANT Neoss, Ltd. | DZE |
| Aug 30, 2012 | K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X Zimmer Dental, Inc. | DZE |
| Aug 10, 2012 | K120847 | ET/SS IMPLANT SYSTEM Osstem Implant Co., Ltd. | DZE |
| Aug 8, 2012 | K112162 | CONICAL CONNECTION IMPLANTS Mis Implants Technologies , Ltd., IL | DZE |
| Aug 6, 2012 | K112532 | ET II BIO-SA FIXTURE SYSTEM Hiossen, Inc. | DZE |
| Jul 31, 2012 | K120414 | OSSEOSPEED PLUS Astra Tech AB | DZE |
| Jul 27, 2012 | K110425 | HC-BIOS DENTAL IMPLANT Hung Chun Bio-S Co., Ltd., TW | DZE |
| Jul 5, 2012 | K120530 | DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S Dentin Implants Technologies , Ltd. | DZE |
| Jul 3, 2012 | K103577 | TRINON Q & Q3 IMPLANT SYSTEM Trinon Titanium GmbH, DE | DZE |
| Jun 18, 2012 | K120503 | CMI IMPLANT IS II ACTIVE Neobiotech Co., Ltd. | DZE |
| Jun 6, 2012 | K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM Straumann USA | DZE |
| Jun 6, 2012 | K120198 | LOCATOR OVERDENTURE IMPLANT SYSTEM Zest Anchors, LLC | DZE |
| Jun 1, 2012 | K111798 | STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... Sterngold Dental, LLC | DZE |
| May 24, 2012 | K112585 | TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM Adin Dental Implants System, Ltd., IL | DZE |
| May 4, 2012 | K112279 | QUANTUM DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. | DZE |
| Apr 27, 2012 | K120043 | CSM INTERNAL-R IMPLANT SYSTEM Csm Implant | DZE |
| Apr 20, 2012 | K112795 | PALTOP DENTAL IMPLANT SYSTEM Paltop Advanced Dental Solutions, Ltd., IL | DZE |
| Apr 18, 2012 | K112440 | AB DENTAL DEVICES IMPLANTS AND ACCESSORIES A.B. Dental Devices , Ltd., IL | DZE |
| Apr 5, 2012 | K113554 | CMI IMPLANT IS SYSTEM Neobiotech Co., Ltd. | DZE |
| Mar 16, 2012 | K110337 | UNIVERSAL MAXILLARY MOLAR Oco Biomedical | DZE |
| Feb 23, 2012 | K112758 | KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 Kat Implants, LLC | DZE |
| Feb 3, 2012 | K112540 | S-MINI IMPLANT SYSTEM Neobiotech Co., Ltd. | DZE |
| Feb 1, 2012 | K111364 | HAPTITE COATING IMPLANT SYSTEM Dentis Co., Ltd. | DZE |
| Jan 27, 2012 | K112875 | BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS Blue Sky Bio, LLC | DZE |
| Jan 13, 2012 | K111162 | SLIM ONEBODY SYSTEM Dentium Co., Ltd. | DZE |
| Dec 14, 2011 | K112160 | TAPERED SCREW-VENT X IMPLANT Zimmer Dental, Inc. | DZE |
| Dec 6, 2011 | K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT Zimmer Dental, Inc. | DZE |
| Nov 22, 2011 | K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM Megagen Co., Ltd. | DZE |
| Nov 18, 2011 | K111216 | OSSEOTITE 2 DENTAL IMPLANTS Biomet 3i, Inc. | DZE |
| Oct 21, 2011 | K112746 | DIOSLIMON IMPLANT SYSTEM Dio Corporation | DZE |
| Oct 14, 2011 | K111120 | CSM SUBMERGED-R IMPLANT SYSTEM Csm Implant | DZE |
| Oct 3, 2011 | K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM Straumann USA | DZE |
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