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OneArch Scan Body HOASB06MU

by OSSTEM IMPLANT Co., Ltd.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800342293885 UDI-DI Date2 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  • Withdrawn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
OneArch Scan Body
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
HOASB06MU
Primary DI / UDI-DI
08800342293885
FDA Product Code
NDP
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (7)

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