Preat Abutments— 510(k) K183518
Substantially EquivalentPreat Corporation
FDA 510(k) clearance K183518 for Preat Abutments, Substantially Equivalent on 2019-03-18. 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
- Grover Beach, 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 K183518
K-number listed on FDA's recall record- Z-2514-2025 — NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
- Z-1987-2025 — Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
- Z-1321-2024 — Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.