510(k) Report

FDA applicant

Shatkin F.I.R.S.T., LLC

Amherst, NY1 decision2019–20190 recalls

FDA records 1 decision for Shatkin F.I.R.S.T., LLC (Amherst, NY) in 2019: 1 510(k) clearance. All are in product code NXC (Aligner, Sequential). Its devices cite 1 predicate, 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 Shatkin F.I.R.S.T., LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Shatkin F.I.R.S.T., LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NXCAligner, Sequential1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K182388Krystal Klear AlignersShatkin F.I.R.S.T., LLC · 2019

The one decision as Shatkin F.I.R.S.T., LLC →