K100993 is an FDA 510(k) clearance for the INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Prismatik Dentalcraft, Inc. (Newport Beach, US). The FDA issued a Cleared decision on December 28, 2010, 263 days after receiving the submission on April 9, 2010.
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 | K100993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2010 |
| Decision Date | December 28, 2010 |
| Days to Decision | 263 days |
| Submission Type | Abbreviated |
| 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. |