FDA · official record K854050Substantially Equivalent

EXCEL BRACKET ADHESIVE

Name: EXCEL BRACKET ADHESIVE — FDA K854050
Creator: Johnson & Johnson Professionals, Inc.
Keywords: EXCEL BRACKET ADHESIVE, EXCEL BRACKET ADHESIVE, K854050, DYH, FDA

United StatesDYHJohnson & Johnson Professionals, Inc.

Verified

Official record identity

FDA application number: K854050
Decision date: November 26, 1985
Published decision: Substantially Equivalent

Classification

Product code: DYH

Published parties

Applicant: Johnson & Johnson Professionals, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-10-03
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3750

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.