FDA · official record K930881Substantially Equivalent

CHANNEL-EDGE BRACKET SYSTEM

Name: CHANNEL-EDGE BRACKET SYSTEM — FDA K930881
Creator: Dualtek, Inc.
Keywords: CHANNEL-EDGE BRACKET SYSTEM, CHANNEL-EDGE BRACKET SYSTEM, K930881, EJF, FDA

United StatesEJFDualtek, Inc.

Verified

Official record identity

FDA application number: K930881
Decision date: January 21, 1994
Published decision: Substantially Equivalent

Classification

Product code: EJF

Published parties

Applicant: Dualtek, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-01-19
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5410

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.