K070533 is an FDA 510(k) clearance for the BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by B.T.I. Biotechnology Institute, Sl. (Minano Menor, Alava, ES). The FDA issued a Cleared decision on June 21, 2007, 115 days after receiving the submission on February 26, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K070533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2007 |
| Decision Date | June 21, 2007 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA - Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |