Skip to content

Ref-Line REF.R4SA2

by POLIDENT d.o.o. 2 variants

Listed FDA GUDID listing, not in commercial distribution

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 NumberEPOLREFR4SA2 UDI-DI Date9 Jun 2021ListedStatusListed GUDID: not 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  • Withdrawn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
Custom-made dental crown, polymer
Model / Ref / Catalog
REF.R4SA2
Primary DI / UDI-DI
EPOLREFR4SA2
FDA Product Code
ELM
GMDN Term
Custom-made dental crown, polymer
Device Class
Class II
Regulation Number
872.3590
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Dry Heat Sterilization
MRI Safety
MR Safe
Size
Outer Diameter — 3 Meter

Other devices from POLIDENT d.o.o.

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

Properties

  • Premarket Exempt

Other properties (13)

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