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Short Abutment MMAH4003

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

Short Abutment MMAH4003 is a Class II device made by InnoBioSurg Co., Ltd(IBS implant Co., Ltd), cleared under FDA 510(k) K220517 on 20 Dec 2022 (1 earlier submission) and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 08800039370332), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800039370332 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220517 Date20 Dec 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220517 decided 20 Dec 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800039370332 listed 4 Jan 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220079
  2. Cleared FDA 510(k) K220517
  3. Listed FDA GUDID 08800039370332

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Short Abutment
Generic name
Dental implant system
Model / reference
MMAH4003
Primary DI / UDI-DI
08800039370332
510(k) Number
FDA product code
DZE
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Other devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

See all devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd) →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (9, all answered No)