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MEDENTiKA E 8121

by MEDENTiKA GmbH

MEDENTiKA E 8121 is a Class II device made by MEDENTiKA GmbH, cleared under FDA 510(k) K223113 on 15 Apr 2024 and listed in FDA GUDID since 1 May 2024 (UDI-DI 04251574850881), 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) K223113

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 Number04251574850881 UDI-DI Date1 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223113 Date15 Apr 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223113 decided 15 Apr 2024 Active
  • FDA GUDID UDI-DI 04251574850881 listed 1 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223113
  2. Listed FDA GUDID 04251574850881

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MEDENTiKA
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
E 8121
Primary DI / UDI-DI
04251574850881
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
MRI safety
MR Conditional

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K223113)

and 8 more cleared under K223113

Similar devices in this category

Other devices filed under Dental implant suprastructure, permanent, preformed.

Other devices from MEDENTiKA GmbH

See all devices from MEDENTiKA GmbH →

Properties

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