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WaveOne® Gold Orifice Shaper Demo TDDW1G1316OSH

by MAILLEFER INSTRUMENTS HOLDING Sàrl

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 NumberJ003TDDW1G1316OSH1 UDI-DI Date24 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  • Withdrawn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
WaveOne® Gold Orifice Shaper Demo
Generic Name
Endodontic obturation system
Model / Ref / Catalog
TDDW1G1316OSH
Primary DI / UDI-DI
J003TDDW1G1316OSH1
FDA Product Code
EKS
GMDN Term
Endodontic obturation system
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No