FDA recall record · openFDA

Preat Corp

11 FDA recalls on record (2023–2025) — 11 device. 11 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implan 3

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the pro 1

Product is labeled with an incorrect expiration date. 1

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually ins 1

Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to h 1

Recalls

NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 Class II 2025-06-25 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used i Class II 2025-04-02 Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only Class II 2025-06-24 Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straum Class II 2024-06-25 Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 Class II 2024-02-09 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous de Class II 2024-04-10 Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 Class II 2023-02-21 Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Class II 2023-07-18 Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental Class II 2023-07-18 Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental Class II 2023-07-18 PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue Class III 2023-02-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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