The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Mis Ti-base Abutment.
| Device ID | K211225 |
| 510k Number | K211225 |
| Device Name: | MIS Ti-base Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Contact | Rebecca Sporer |
| Correspondent | Rebecca Sporer Dentsply Sirona 221 West Philadelphia Street, Suite 60W York, PA 17401 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109019994 | K211225 | 000 |
| 07290109003672 | K211225 | 000 |
| 07290109003757 | K211225 | 000 |
| 07290109003771 | K211225 | 000 |
| 07290109003795 | K211225 | 000 |
| 07290109003818 | K211225 | 000 |
| 07290109003825 | K211225 | 000 |
| 07290109003931 | K211225 | 000 |
| 07290109012490 | K211225 | 000 |
| 07290109019864 | K211225 | 000 |
| 07290109019888 | K211225 | 000 |
| 07290109019970 | K211225 | 000 |
| 07290109003665 | K211225 | 000 |