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Primodent PRV.34IA9

by POLIDENT d.o.o. 2 variants

Primodent PRV.34IA9 is a Class II device made by POLIDENT d.o.o., listed in FDA GUDID since 15 Jun 2021 (UDI-DI EPOLPRV34IA9), not in commercial distribution (GUDID) as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPOLPRV34IA9 UDI-DI Date15 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  • Withdrawn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
Primodent
Generic name
Partial denture
Model / Ref / Catalog
PRV.34IA9
Primary DI / UDI-DI
EPOLPRV34IA9
FDA product code
ELM
GMDN term
Partial denture
Device class
Class II
Regulation number
872.3590
GUDID distribution status
Not in Commercial Distribution
Sterilisation 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

  • Sterilise before use
Other properties (14, all answered No)