FDA · official record K123638Substantially Equivalent

PEKKTON IVORY

Name: PEKKTON IVORY — FDA K123638
Creator: Cendres & Metaux SA
Keywords: PEKKTON IVORY, PEKKTON IVORY, K123638, EBG, FDA

United StatesEBGCendres & Metaux SA

Verified

Official record identity

FDA application number: K123638
Decision date: February 21, 2013
Published decision: Substantially Equivalent

Classification

Product code: EBG

Published parties

Applicant: Cendres & Metaux SA

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-11-26
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.