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Surtex SST

by Dentatus AB

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 Number07350081493523 UDI-DI Date20 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Surtex
Generic name
Root canal post, preformed
Model / Ref / Catalog
SST
Primary DI / UDI-DI
07350081493523
FDA product code
ELR, EJB
GMDN term
Root canal post, preformed
Device class
Class I
Regulation number
872.3810, 872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Liquid Chemical

Related devices

Category: Root canal post, preformed

Other devices from Dentatus AB

See all devices from Dentatus AB →

Properties

  • Sterilise before use
  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date

Other properties (9)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No