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ET IV Fixture NH Regular No Mounted ET IV Fixture SA Regular No Mounted CET4R4018S

by Hiossen Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810126046284 UDI-DI Date7 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ET IV Fixture NH Regular No Mounted ET IV Fixture SA Regular No Mounted
Generic Name
Screw endosteal dental implant, two-piece
Model / Reference
CET4R4018S
Primary DI / UDI-DI
00810126046284
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution

Other devices from Hiossen Inc.

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Properties

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

Other properties (7)

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