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SHINING 3D® HACS Kit

by Shining 3D Tech 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 Number06942799001100 UDI-DI Date9 Oct 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  • Withdrawn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
Shining 3D®
Generic Name
Dental implant abutment analog, laboratory
Model / Reference
HACS Kit
Primary DI / UDI-DI
06942799001100
FDA Product Code
NDP
GMDN Term
Dental implant abutment analog, laboratory
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Shining 3D Tech Co., Ltd.

See all devices from Shining 3D Tech Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No