510(k) Report

FDA applicant

Ross Healthcare, Inc.

Blaine, WA1 decision2012–20120 recalls

FDA records 1 decision for Ross Healthcare, Inc. (Blaine, WA) in 2012: 1 510(k) clearance. All are in product code LBH (Varnish, Cavity). 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 Ross Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 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 — Ross Healthcare, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LBHVarnish, Cavity1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K113146PCXX VarnishRoss Healthcare, Inc. · 2012

The one decision as Ross Healthcare, Inc. →

Other applicant names beginning “Ross”

FDA records each applicant name separately; these may or may not be the same firm.

Ross Products 4Ross Product Div. Abbott Laboratories 4Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn 2Ross Research, Inc. 2Ross Creek Medical, Inc. 1Ross Implant Technologies Corp., Inc. 1Ross Medical Technology, Inc. 1