FDA · official record K033773Substantially Equivalent

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL

Name: CONCEPT HP ADD-ON; CONCEPT HP ENAMEL — FDA K033773
Creator: Ivoclar Vivadent, AG
Keywords: CONCEPT HP ADD-ON; CONCEPT HP ENAMEL, CONCEPT HP ADD-ON; CONCEPT HP ENAMEL, K033773, EBF, FDA

United StatesEBFIvoclar Vivadent, AG

Verified

Official record identity

FDA application number: K033773
Decision date: January 15, 2004
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Ivoclar Vivadent, AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-12-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.