FDA · official record K112574Substantially Equivalent

PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT

Name: PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT — FDA K112574
Creator: Prime Dental Manufacturing, Inc.
Keywords: PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT, PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT, K112574, EMA, FDA

United StatesEMAPrime Dental Manufacturing, Inc.

Verified

Official record identity

FDA application number: K112574
Decision date: January 23, 2012
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Prime Dental Manufacturing, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-09-06
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3275

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.