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Preat 710505

by PREAT Corporation

Preat 710505 is a Class II device made by PREAT Corporation, cleared under FDA 510(k) K251547 on 31 Oct 2025 and listed in FDA GUDID since 22 Dec 2025 (UDI-DI 00842092185131), 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) K251547

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 Number00842092185131 UDI-DI Date22 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251547 Date31 Oct 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251547 decided 31 Oct 2025 Active
  • FDA GUDID UDI-DI 00842092185131 listed 22 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251547
  2. Listed FDA GUDID 00842092185131

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  • Withdrawn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
710505
Description
PreatLoc™ Hiossen® ETIII-compatible Mini Abutment 5mm
Primary DI / UDI-DI
00842092185131
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

Cleared under the same submission (K251547)

and 8 more cleared under K251547

Similar devices

Other devices filed under FDA product code NHA (Abutment, Implant, Dental, Endosseous).

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)