510(k) Report

FDA applicant

Preat Corporation

Santa Maria, CA4 decisions1981–20259 recalls

FDA records 4 decisions for Preat Corporation (Santa Maria, CA) from 1981 to 2025: 4 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and ECG (Sterilizer, Boiling Water). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Preat Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Preat Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12022: 12025: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2025

2023: 42024: 22025: 3
2007high 4 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Preat Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Preat Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous3decisions
  • ECGSterilizer, Boiling Water1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 147 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183518Preat AbutmentsPreat Corporation · 20194cite it
  • K220823Preat AbutmentsPreat Corporation · 20221cites it

What has FDA decided for it lately?

  • K243824Preat AbutmentsPreat Corporation · 2025
  • K220823Preat AbutmentsPreat Corporation · 20226 recalls
  • K183518Preat AbutmentsPreat Corporation · 20193 recalls
  • K810977Endodontic Post SystemsPreat Corp. · 1981

All 3 as Preat Corporation →The one decision as Preat Corp. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K183518NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662Jun 25, 2025Class II
  • K220823Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10…Jun 24, 2025Class II
  • K183518Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled…Apr 2, 2025Class II
  • K2208239006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in…Apr 10, 2024Class II
  • K183518Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967Feb 9, 2024Class II
  • K220823Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use…Jul 18, 2023Class II