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Implant Prosthetics 9000577

by PREAT Corporation

Implant Prosthetics 9000577 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K183518 on 18 Mar 2019 and listed in FDA GUDID since 28 Jun 2022 (UDI-DI 00842092130988), active as of 22 Oct 2026. 3 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

3 ongoing

This device is named in the recall

Documents

510(k) K183518

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 Number00842092130988 UDI-DI Date28 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183518 Date18 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183518 decided 18 Mar 2019 Active
  • FDA GUDID UDI-DI 00842092130988 listed 28 Jun 2022 Listed

Recalls

3 recalls · 3 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-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-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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K183518
  2. Listed FDA GUDID 00842092130988
  3. Recall initiated FDA recalls Z-1321-2024
  4. Recall initiated FDA recalls Z-1987-2025
  5. Recall initiated FDA recalls Z-2514-2025

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  • Withdrawn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 implant suprastructure, permanent, preformed
Model / Ref / Catalog
9000577
Primary DI / UDI-DI
00842092130988
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
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K183518)

and 8 more cleared under K183518

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)