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Thermafil for GT GTOB40043

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 NumberJ003GTOB400431 UDI-DI Date26 Mar 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  • Withdrawn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
Thermafil for GT
Generic Name
Warm-bonded endodontic obturation system obturator
Model / Ref / Catalog
GTOB40043
Primary DI / UDI-DI
J003GTOB400431
FDA Product Code
EKM
GMDN Term
Warm-bonded endodontic obturation system obturator
Device Class
Class I
Regulation Number
872.3850
GUDID distribution status
In Commercial Distribution

Other devices from MAILLEFER INSTRUMENTS HOLDING Sàrl

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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