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Directa Temporary Polycarbonate Crowns 50

by Directa AB

Directa Temporary Polycarbonate Crowns 50 (609250) is a Class I device made by Directa AB, listed in FDA GUDID since 7 Dec 2022 (UDI-DI 17310236092503), 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 Number17310236092503 UDI-DI Date7 Dec 2022ListedStatusListed 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  • Withdrawn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
Directa Temporary Polycarbonate Crowns
Generic name
Preformed dental crown, temporary
Model / Ref / Catalog
50, 609250
Primary DI / UDI-DI
17310236092503
FDA product code
ELZ
GMDN term
Preformed dental crown, temporary
Device class
Class I
Regulation number
872.3330
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Preformed dental crown, temporary

Other devices from Directa AB

See all devices from Directa AB →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)