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Prosthetic Accessories P0NC-4, 3

by A.B. Dental Devices Ltd

Prosthetic Accessories P0NC-4, 3 (P0NC-4,3) is a Class II device made by A.B. Dental Devices Ltd, cleared under FDA 510(k) K250806 on 18 Jun 2026 and listed in FDA GUDID since 24 Aug 2026 (UDI-DI 07290111272226), 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) K250806

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 Number07290111272226 UDI-DI Date24 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250806 Date18 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250806 decided 18 Jun 2026 Active
  • FDA GUDID UDI-DI 07290111272226 listed 24 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250806
  2. Listed FDA GUDID 07290111272226

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prosthetic Accessories
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
P0NC-4, 3
Primary DI / UDI-DI
07290111272226
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K250806)

and 8 more cleared under K250806

Similar devices

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

Other devices from A.B. Dental Devices Ltd

See all devices from A.B. Dental Devices Ltd →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)