K983742 is an FDA 510(k) clearance for the ITI DENTAL IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on March 15, 1999, 143 days after receiving the submission on October 23, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K983742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1998 |
| Decision Date | March 15, 1999 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |