510(k) Report

FDA applicant

Dentca, Inc.

Torrance, CA6 decisions2015–20260 recalls

FDA records 6 decisions for Dentca, Inc. (Torrance, CA) from 2015 to 2026: 6 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Dentca, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12017: 22020: 12022: 12026 (partial year): 1
2015high 2 (2017) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Dentca, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dentca, Inc.’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?

  • EBIResin, Denture, Relining, Repairing, Rebasing4decisions
  • EBGCrown And Bridge, Temporary, Resin1decision
  • PZYAdditively Manufactured, Preformed, Resin Denture Tooth1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 174 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 174 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 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.

  • K162044Dentca Denture Base IIDentca, Inc. · 20176cite it
  • K143033Dentca Denture BaseDentca, Inc. · 20152cite it
  • K192806DENTCA Crown and BridgeDentca, Inc. · 20202cite it
  • K172398DENTCA DENTURE TeethDentca, Inc. · 20172cite it
  • K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 20222cite it

What has FDA decided for it lately?

  • K261474DENTCA Tru FlexibleDentca, Inc. · 2026
  • K220042Dentca Base Premium, Dentca Base Hi-ImpactDentca, Inc. · 2022
  • K192806DENTCA Crown and BridgeDentca, Inc. · 2020
  • K172398DENTCA DENTURE TeethDentca, Inc. · 2017
  • K162044Dentca Denture Base IIDentca, Inc. · 2017
  • K143033Dentca Denture BaseDentca, Inc. · 2015

All 6 as Dentca, Inc. →