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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2004 | Implant Innovations, Inc. EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Terminated |
DZE | K934126 |
| Jul 23, 2004 | Zimmer Dental Inc Taperlock Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Swissplus Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Swedevent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Screwvent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Microvent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Biovent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Advent Implant Line Terminated |
DZE | None listed |
| Jul 20, 2004 | The Straumann Company Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel
Article No. 044.088 Terminated |
DZE | None listed |
| Jun 17, 2003 | Implant Innovations, Inc. Products are surgical drills packaged separately or included in a surgical kit so two products will be listed.
The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 Osseo Terminated |
DZE | None listed |
| Jun 17, 2003 | Implant Innovations, Inc. Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be Terminated |
DZE | None listed |
| Mar 20, 2003 | Implant Innovations, Inc. LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile, Terminated |
DZE | K950204 |
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