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Thermafil Plus SVN655

by Tulsa Dental Products LLC

Thermafil Plus SVN655 is a Class I device made by Tulsa Dental Products LLC, listed in FDA GUDID since 30 Aug 2022 (UDI-DI D716SVN6551), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD716SVN6551 UDI-DI Date30 Aug 2022ListedStatusListed 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  • Withdrawn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 Plus
Generic name
Manual endodontic file/rasp, reusable
Model / Ref / Catalog
SVN655
Description
Verifier: NT 6pk 55/25mm
Primary DI / UDI-DI
D716SVN6551
FDA product code
EIL
GMDN term
Manual endodontic file/rasp, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Manual endodontic file/rasp, reusable

Similar devices in this category

Other devices filed under Manual endodontic file/rasp, reusable.

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Properties

  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)