FDA · official record K936244Substantially Equivalent

REGENCY BRACKET

Name: REGENCY BRACKET — FDA K936244
Creator: Mid-American Dental Specialties, Inc.
Keywords: REGENCY BRACKET, REGENCY BRACKET, K936244, EJF, FDA

United StatesEJFMid-American Dental Specialties, Inc.

Verified

Official record identity

FDA application number: K936244
Decision date: February 02, 1994
Published decision: Substantially Equivalent

Classification

Product code: EJF

Published parties

Applicant: Mid-American Dental Specialties, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-12-30
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.