510(k) Report

FDA applicant

Bite Tech, Inc.

Norwalk, CT1 decision2016–20160 recalls

FDA records 1 decision for Bite Tech, Inc. (Norwalk, CT) in 2016: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). 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

How often FDA has decided Bite Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Bite Tech, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Bite”

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