FDA · official record K143330Substantially Equivalent

BruxZir Anterior

Name: BruxZir Anterior — FDA K143330
Creator: Prismatik Dentalcraft, Inc.
Keywords: BruxZir Anterior, BruxZir Anterior, K143330, EIH, FDA

United StatesEIHPrismatik Dentalcraft, Inc.

Verified

Official record identity

FDA application number: K143330
Decision date: December 15, 2014
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Prismatik Dentalcraft, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2014-11-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

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.