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Preat 9003731-100

by PREAT Corporation

Preat 9003731-100 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K220823 on 26 Oct 2022 and listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00842092174999), active as of 22 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

510(k) K220823

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842092174999 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220823 Date26 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220823 decided 26 Oct 2022 Active
  • FDA GUDID UDI-DI 00842092174999 listed 9 Jun 2026 Listed

Recalls

6 recalls · 6 ongoing · FDA

    • Ongoing Z-2107-2025 FDA Class II initiated 24 Jun 2025

    Due to manufacturing error, digital analog rotational feature is 180 degrees off.

    • Ongoing Z-2318-2024 FDA Class II initiated 10 Apr 2024

    Due to incorrect milled titanium abutment being packaged and labeled.

  • 3 recalls, same reason

    • Ongoing Z-0153-2024 FDA Class II initiated 18 Jul 2023
    • Ongoing Z-0154-2024 FDA Class II initiated 18 Jul 2023
    • Ongoing Z-0152-2024 FDA Class II initiated 18 Jul 2023

    The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

    • Ongoing Z-1285-2023 FDA Class II initiated 21 Feb 2023

    Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

Timeline

8 dated events

  1. Cleared FDA 510(k) K220823
  2. Recall initiated FDA recalls Z-1285-2023
  3. Recall initiated FDA recalls Z-0153-2024
  4. Recall initiated FDA recalls Z-0154-2024
  5. Recall initiated FDA recalls Z-0152-2024
  6. Recall initiated FDA recalls Z-2318-2024
  7. Recall initiated FDA recalls Z-2107-2025
  8. Listed FDA GUDID 00842092174999

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Preat
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
9003731-100
Primary DI / UDI-DI
00842092174999
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3630
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K220823)

and 8 more cleared under K220823

Other devices from PREAT Corporation

  • Preat 9001230-10 Open recall

    Class II

  • Preat 710106

    Class II

  • Preat 710045

    Class II

  • Preat 710046

    Class II

See all devices from PREAT Corporation →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Combination product
  • Lot / batch number
  • Manufacturing date
Other properties (8, all answered No)