FDA · official record K151646Substantially Equivalent

ProTech Plus

Name: ProTech Plus — FDA K151646
Creator: Protech Professional Products, Inc.
Keywords: ProTech Plus, ProTech Plus, K151646, EBI, FDA

United StatesEBIProtech Professional Products, Inc.

Verified

Official record identity

FDA application number: K151646
Decision date: October 21, 2015
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Protech Professional Products, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2015-06-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3760

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.