FDA · official record K162598Substantially Equivalent

HAPI Seal

Name: HAPI Seal — FDA K162598
Creator: Bisco, Inc.
Keywords: HAPI Seal, HAPI Seal, K162598, EBC, FDA

United StatesEBCBisco, Inc.

Verified

Official record identity

FDA application number: K162598
Decision date: May 23, 2017
Published decision: Substantially Equivalent

Classification

Product code: EBC

Published parties

Applicant: Bisco, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-09-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3765

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.