Preat Abutments— 510(k) K220823
Substantially EquivalentPreat Corporation
FDA 510(k) clearance K220823 for Preat Abutments, Substantially Equivalent on 2022-10-26. Applicant: Preat Corporation. Device class: 2.
Clearance details
- Applicant
- Preat Corporation
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Recent devices under product code NHA
view allMore clearances from Preat Corporation
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K220823
K-number listed on FDA's recall record- Z-2107-2025 — Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- Z-2318-2024 — 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.
- Z-0152-2024 — Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Z-0153-2024 — Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Z-0154-2024 — Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
- Z-1285-2023 — Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220823.
Data sourced from openFDA. This site is unofficial and independent of the FDA.