FDA · official record K151540Substantially Equivalent

MC BIO Supertack Tack 3mm, 4mm and 5mm

Name: MC BIO Supertack Tack 3mm, 4mm and 5mm — FDA K151540
Creator: Eli-Ka Technologies
Keywords: MC BIO Supertack Tack 3mm, 4mm and 5mm, MC BIO Supertack Tack 3mm, 4mm and 5mm, K151540, DZL, FDA

United StatesDZLEli-Ka Technologies

Verified

Official record identity

FDA application number: K151540
Decision date: May 26, 2016
Published decision: Substantially Equivalent

Classification

Product code: DZL

Published parties

Applicant: Eli-Ka Technologies

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2015-06-08
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4880

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.