510(k) Report

FDA applicant

Dentalview, Inc.

Irvine, CA2 decisions1997–19981 recall

FDA records 2 decisions for Dentalview, Inc. (Irvine, CA) from 1997 to 1998: 2 510(k) clearances. All are in product code EIA (Unit, Operative Dental). 1 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 Dentalview, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentalview, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dentalview, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIAUnit, Operative Dental2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K982480Perioview Model DV-1 Fiberscope and Window Sheath.Dentalview, Inc. · 19981cites it

What has FDA decided for it lately?

  • K982480Perioview Model DV-1 Fiberscope and Window Sheath.Dentalview, Inc. · 19981 recall
  • K973492Dentalview Perioview SystemDentalview, Inc. · 1997

All 2 as Dentalview, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K982480Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile…Jun 24, 2016Class II