FDA · official record K121749Substantially Equivalent

VERACIA

Name: VERACIA — FDA K121749
Creator: Shofu Dental Corporation
Keywords: VERACIA, VERACIA, K121749, ELM, FDA

United StatesELMShofu Dental Corporation

Verified

Official record identity

FDA application number: K121749
Decision date: September 07, 2012
Published decision: Substantially Equivalent

Classification

Product code: ELM

Published parties

Applicant: Shofu Dental Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2012-06-14
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3590

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.