FDA applicant

Alpine Oral Care, LLC

Houston, TX1 decision2007–20070 recalls

FDA records 1 decision for Alpine Oral Care, LLC (Houston, TX) in 2007: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). 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

How often FDA has decided Alpine Oral Care, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alpine Oral Care, LLC’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

Other applicant names beginning “Alpine”

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

Alpine Dental Equipment Co. 10 Alpine Specialties, Inc. 2 Alpine Biomed Aps 1

Alpine Oral Care, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Alpine”