FDA · official record K123697Substantially Equivalent

MATRICEL DENTAL BARRIER MEMBRANE

Name: MATRICEL DENTAL BARRIER MEMBRANE — FDA K123697
Creator: Matricel GmbH
Keywords: MATRICEL DENTAL BARRIER MEMBRANE, MATRICEL DENTAL BARRIER MEMBRANE, K123697, NPL, FDA

United StatesNPLMatricel GmbH

Verified

Official record identity

FDA application number: K123697
Decision date: February 24, 2014
Published decision: Substantially Equivalent

Classification

Product code: NPL

Published parties

Applicant: Matricel GmbH

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-12-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.