K141923 is an FDA 510(k) clearance for the INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on January 6, 2015, 174 days after receiving the submission on July 16, 2014.
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 | K141923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2014 |
| Decision Date | January 06, 2015 |
| Days to Decision | 174 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. |