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Ref-Line REF.U3A9

by POLIDENT d.o.o. 2 variants

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 NumberEPOLREFU3A350 UDI-DI Date6 Dec 2024ListedStatusListed 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  • Withdrawn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
Ref-Line
Generic name
Resin artificial teeth
Model / Ref / Catalog
REF.U3A9
Primary DI / UDI-DI
EPOLREFU3A350
FDA product code
ELM
GMDN term
Resin artificial teeth
Device class
Class II
Regulation number
872.3590
GUDID distribution status
In Commercial Distribution

Related devices

Category: Resin artificial teeth

Other devices from POLIDENT d.o.o.

See all devices from POLIDENT d.o.o. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No