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Ball Abutment AANBAF0060

by Megagen Implant Co. Ltd

Ball Abutment AANBAF0060 is a Class II device made by Megagen Implant Co. Ltd, cleared under FDA 510(k) K110955 on 22 Nov 2011 and listed in FDA GUDID since 23 Jun 2015 (UDI-DI 08806388200924), active as of 23 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 23 Oct 2026

Documents

510(k) K110955

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806388200924 UDI-DI Date23 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110955 Date22 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110955 decided 22 Nov 2011 Active
  • FDA GUDID UDI-DI 08806388200924 listed 23 Jun 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110955
  2. Listed FDA GUDID 08806388200924

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ball Abutment
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
AANBAF0060
Description
AnyRidge Internal C=6
Primary DI / UDI-DI
08806388200924
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

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (8, all answered No)