510(k) Report

FDA applicant

Colbar Lifescience, Ltd.

Washington, DC2 decisions2006–20080 recalls

FDA records 2 decisions for Colbar Lifescience, Ltd. (Washington, DC) from 2006 to 2008: 1 510(k) clearance and 1 original PMA approval. Most are in product codes NPL (Barrier, Animal Source, Intraoral) and LMH (Implant, Dermal, For Aesthetic Use). 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 Colbar Lifescience, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Colbar Lifescience, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Colbar Lifescience, Ltd.’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