510(k) Report

FDA applicant

Prevest Denpro Limited

Bari Brahmana, IN7 decisions2021–20240 recalls

FDA records 7 decisions for Prevest Denpro Limited (Bari Brahmana, IN) from 2021 to 2024: 7 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KIF (Resin, Root Canal Filling). Since 2016 its 510(k)s took a median of 314 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 20 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 Prevest Denpro Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2021: 12022: 32023: 12024: 2
2021high 3 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Prevest Denpro Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prevest Denpro Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin2decisions
  • KIFResin, Root Canal Filling1decision
  • ELWMaterial, Impression1decision
  • EMACement, Dental1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision
  • KLEAgent, Tooth Bonding, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 314 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 120 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 20 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.

  • K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and…Prevest Denpro Limited · 20222cite it

What has FDA decided for it lately?

  • K233273C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited · 2024
  • K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited · 2024
  • K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalPrevest Denpro Limited · 2023
  • K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and…Prevest Denpro Limited · 2022
  • K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/LiquidPrevest Denpro Limited · 2022
  • K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited · 2022
  • K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting…Prevest Denpro Limited · 2021

All 7 as Prevest Denpro Limited →