FDA · official record K132067Substantially Equivalent

MULTI ANGLED ABUTMENT SYSTEM

Name: MULTI ANGLED ABUTMENT SYSTEM — FDA K132067
Creator: Hiossen, Inc.
Keywords: MULTI ANGLED ABUTMENT SYSTEM, MULTI ANGLED ABUTMENT SYSTEM, K132067, NHA, FDA

United StatesNHAHiossen, Inc.

Verified

Official record identity

FDA application number: K132067
Decision date: December 20, 2013
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Hiossen, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2013-07-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.