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Preat 7100018-10

by PREAT Corporation

Preat 7100018-10 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K222288 on 27 Oct 2022 and listed in FDA GUDID since 24 Jul 2025 (UDI-DI 00842092186251), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K222288

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 Number00842092186251 UDI-DI Date24 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222288 Date27 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222288 decided 27 Oct 2022 Active
  • FDA GUDID UDI-DI 00842092186251 listed 24 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222288
  2. Listed FDA GUDID 00842092186251

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  • Withdrawn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
7100018-10
Description
PreatLoc™ Abutment for Bar, 2.0mm Thread, 10 Pack
Primary DI / UDI-DI
00842092186251
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

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)