Preat Implant Prosthetics 9006767Recalls & reported problems

Preat Corporation · Astra® EV-compatible 4.8mm Titanium Blank Kit contains: 1 Astra® EV-compatible 4.8mm Titanium Blank 2 Astra® EV-compatible 4.8/5.4 mm Titanium Screws · Class 2 · Implant

All models of Preat Implant Prosthetics (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K220823); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 10, 2024Class IIOpen, Classified
Due to incorrect milled titanium abutment being packaged and labeled.
Z-2318-2024 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220823. One submission often covers many models, so check the product and lot details in each record.

Z-2107-2025 · Jun 24, 2025 · Open, Classified
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Z-0154-2024 · Jul 18, 2023 · Open, Classified
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Z-0153-2024 · Jul 18, 2023 · Open, Classified
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Z-0152-2024 · Jul 18, 2023 · Open, Classified
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Z-1285-2023 · Feb 21, 2023 · Open, Classified
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Device details

UDI-DI	`00842092159477`
Brand	Preat Implant Prosthetics
Model	9006767
Company	Preat Corporation
Product code	PNP · Dental Abutment Design Software For Dental Laboratory
Class	Class 2
FDA submission	K220823
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 27, 2025

Device type (GMDN): Dental implant suprastructure, permanent, preformed

A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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