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Implantium, Superline IHAB6006TN

by Dentium Co., Ltd.

Implantium, Superline IHAB6006TN is a Class II device made by Dentium Co., Ltd., cleared under FDA 510(k) K191634 on 4 Nov 2019 and listed in FDA GUDID since 20 Aug 2021 (UDI-DI 08809691364727), 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) K191634

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 Number08809691364727 UDI-DI Date20 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191634 Date4 Nov 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191634 decided 4 Nov 2019 Active
  • FDA GUDID UDI-DI 08809691364727 listed 20 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191634
  2. Listed FDA GUDID 08809691364727

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Implantium, Superline
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
IHAB6006TN
Primary DI / UDI-DI
08809691364727
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
MRI safety
MR Conditional
Size
Outer Diameter — 6 Millimeter

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Cleared under the same submission (K191634)

and 8 more cleared under K191634

Similar devices in this category

Other devices filed under Dental implant suprastructure, temporary, preformed, single-use.

Other devices from Dentium Co., Ltd.

See all devices from Dentium Co., Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (6, all answered No)