The following data is part of a premarket notification filed by Keystone Dental Inc. with the FDA for Kdg Abutments.
| Device ID | K221381 |
| 510k Number | K221381 |
| Device Name: | KDG Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Keystone Dental Inc. 154 Middlesex Turnpike Burlington, MA 01803 |
| Contact | Nancy DeAngelo |
| Correspondent | Chris Brown Aclivi, LLC 3250 Brackley Drive Ann Arbor, MI 48105 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-08-10 |