510(k) Report

FDA applicant

Intl. Dental Design Specialists, Inc.

Imperial Beach, CA1 decision1997–19970 recalls

FDA records 1 decision for Intl. Dental Design Specialists, Inc. (Imperial Beach, CA) in 1997: 1 510(k) clearance. All are in product code LCN (Scraper, Tongue). 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 Intl. Dental Design Specialists, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Dental Design Specialists, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Intl. Dental Design Specialists, Inc.’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?

  • LCNScraper, Tongue1decision

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.

  • K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 19972cite it

What has FDA decided for it lately?

  • K972644Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997

The one decision as Intl. Dental Design Specialists, Inc. →