COLLAGEN DENTAL MEMBRANE III— 510(k) K062846

Name: FDA 510(k) clearance K062846
Creator: U.S. Food and Drug Administration
Published: 2006-10-13

Substantially Equivalent

Collagen Matrix, Inc.

FDA 510(k) clearance K062846 for COLLAGEN DENTAL MEMBRANE III, Substantially Equivalent on 2006-10-13. Applicant: Collagen Matrix, Inc.. Device class: 2.

Clearance details

Applicant: Collagen Matrix, Inc.
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2006-09-22
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K062846

K-number listed on FDA's recall record

Z-0414-2019 — BioMend Extend, REF# 0142Z, Synthetic bone grafting material.Class III·Terminated·Collagen Matrix, Inc.·20180816

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062846.

Data sourced from openFDA. This site is unofficial and independent of the FDA.