FDA · official record K101064Substantially Equivalent

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P

Name: BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P — FDA K101064
Creator: Bredent GmbH & Co. KG
Keywords: BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P, BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P, K101064, ELM, FDA

United StatesELMBredent GmbH & Co. KG

Verified

Official record identity

FDA application number: K101064
Decision date: September 14, 2010
Published decision: Substantially Equivalent

Classification

Product code: ELM

Published parties

Applicant: Bredent GmbH & Co. KG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-04-16
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3590

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.