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Primodent PRI.32IG6

by POLIDENT d.o.o. 2 variants

Primodent PRI.32IG6 is a Class II device made by POLIDENT d.o.o., cleared under FDA 510(k) K926070 on 17 Feb 1994 and listed in FDA GUDID since 10 Dec 2024 (UDI-DI EPOLPRI32IG60), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K926070

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPOLPRI32IG60 UDI-DI Date10 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK926070 Date17 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K926070 decided 17 Feb 1994 Active
  • FDA GUDID UDI-DI EPOLPRI32IG60 listed 10 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K926070
  2. Listed FDA GUDID EPOLPRI32IG60

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Primodent
Generic name
Resin artificial teeth
Model / Ref / Catalog
PRI.32IG6
Primary DI / UDI-DI
EPOLPRI32IG60
510(k) Number
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

Cleared under the same submission (K926070)

and 8 more cleared under K926070

Other devices from POLIDENT d.o.o.

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

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)