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EK 30° Multi Angled abutment EK30MA4830TH

by Hiossen Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810125998669 UDI-DI Date4 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EK 30° Multi Angled abutment
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
EK30MA4830TH
Primary DI / UDI-DI
00810125998669
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

Related devices

Cleared under the same submission (K251427)

Other devices from Hiossen Inc.

See all devices from Hiossen Inc. →

Properties

  • Single Use
  • Implantable
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No