The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for High Retention Attachment System.
Device ID | K220252 |
510k Number | K220252 |
Device Name: | High Retention Attachment System |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Zest Anchors, LLC 2875 Loker East Carlsbad, CA 92026 |
Contact | Richard Hines |
Correspondent | Richard Hines Zest Anchors, LLC 2875 Loker East Carlsbad, CA 92026 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-31 |
Decision Date | 2022-04-14 |