FDA · official record K162537Substantially Equivalent

CAD/CAMouflage Milling Block

Name: CAD/CAMouflage Milling Block — FDA K162537
Creator: Prismatik Dentalcraft, Inc.
Keywords: CAD/CAMouflage Milling Block, CAD/CAMouflage Milling Block, K162537, EBF, FDA

United StatesEBFPrismatik Dentalcraft, Inc.

Verified

Official record identity

FDA application number: K162537
Decision date: November 16, 2016
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Prismatik Dentalcraft, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2016-09-12
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.