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Amii Implant 554M5009S

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

Amii Implant 554M5009S is a Class II device made by InnoBioSurg Co., Ltd(IBS implant Co., Ltd), cleared under FDA 510(k) K192197 on 28 Apr 2020 and listed in FDA GUDID since 23 Apr 2025 (UDI-DI 08809986616371), 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) K192197

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 Number08809986616371 UDI-DI Date23 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192197 Date28 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192197 decided 28 Apr 2020 Active
  • FDA GUDID UDI-DI 08809986616371 listed 23 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192197
  2. Listed FDA GUDID 08809986616371

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amii Implant
Generic name
Dental implant system
Model / reference
554M5009S
Primary DI / UDI-DI
08809986616371
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
MRI safety
MR Unsafe

Related devices

Category: Dental implant system

Cleared under the same submission (K192197)

and 8 more cleared under K192197

Similar devices in this category

Other devices filed under Dental implant system.

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

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

Properties

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