510(k) K220823 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Abutments
| Applicant | Preat Corporation, Santa Maria CA, US |
| Decision | Substantially Equivalent, Oct 26, 2022 |
| Received | Mar 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Preat Corp Preat, Astra EV-compatible 4.2mm Digital Analog
REF: 9006603 (single) and 9006603-10(10 pack), Rx Only Open, Classified |
NHA | None listed |
| Jul 8, 2024 | Preat Corp 9006767 Astra EV 4.8mm Milled Titanium Abutment
Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. Open, Classified |
NHA | None listed |
| Oct 24, 2023 | Preat Corp Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | None listed |
| Oct 24, 2023 | Preat Corp Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | None listed |
| Oct 24, 2023 | Preat Corp Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental Open, Classified |
NHA | None listed |
| Mar 24, 2023 | Preat Corp Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.