Skip to content

Implant Prosthetics 9003751

by PREAT Corporation 2 variants

Implant Prosthetics 9003751 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K220823 on 26 Oct 2022 (1 earlier submission) and listed in FDA GUDID since 1 Sep 2022 (UDI-DI 00842092165287), active as of 22 Oct 2026. 9 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220823 Date26 Oct 2022DecidedStatusActive
United StatesGUDID listing Number00842092165287 UDI-DI Date1 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220823 decided 26 Oct 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00842092165287 listed 1 Sep 2022 Listed

Recalls

9 recalls · 9 ongoing · FDA

    • Ongoing Z-2514-2025 FDA Class II initiated 25 Jun 2025

    Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.

    • 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-1987-2025 FDA Class II initiated 2 Apr 2025

    Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

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

    Due to incorrect milled titanium abutment being packaged and labeled.

    • Ongoing Z-1321-2024 FDA Class II initiated 9 Feb 2024

    Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.

  • 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

12 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-1321-2024
  7. Recall initiated FDA recalls Z-2318-2024
  8. Recall initiated FDA recalls Z-1987-2025
  9. Recall initiated FDA recalls Z-2107-2025
  10. Recall initiated FDA recalls Z-2514-2025

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Implant Prosthetics
Generic name
Dental prosthesis/implant abutment screw
Model / Ref / Catalog
9003751
Primary DI / UDI-DI
00842092165287
510(k) Number
FDA product code
NHA
GMDN term
Dental prosthesis/implant abutment screw
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Related devices

Category: Dental prosthesis/implant abutment screw

Cleared under the same submission (K183518)

and 8 more cleared under K183518

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
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)