FDA · official record K103474Substantially Equivalent

ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

Name: ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) — FDA K103474
Creator: Micerium S.P.A.
Keywords: ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT), ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT), K103474, EBG, FDA

United StatesEBGMicerium S.P.A.

Verified

Official record identity

FDA application number: K103474
Decision date: February 07, 2011
Published decision: Substantially Equivalent

Classification

Product code: EBG

Published parties

Applicant: Micerium S.P.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2010-11-26
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3770

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.