510(k) Report

FDA applicant

Polident D.O.O., Dental Products Industry

Volcja Draga, SI2 decisions2012–20160 recalls

FDA records 2 decisions for Polident D.O.O., Dental Products Industry (Volcja Draga, SI) from 2012 to 2016: 2 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBG (Crown And Bridge, Temporary, Resin). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Polident D.O.O., Dental Products Industry’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12016: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Polident D.O.O., Dental Products Industry by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polident D.O.O., Dental Products…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry · 20161cites it
  • K112967Pmma Cad/Cam DiscPolident D.O.O., Dental Products Industry · 20121cites it

What has FDA decided for it lately?

  • K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry · 2016
  • K112967Pmma Cad/Cam DiscPolident D.O.O., Dental Products Industry · 2012

All 2 as Polident D.O.O., Dental Products Industry →