FDA · official record K833598Substantially Equivalent

LEBLOND DIAMOND DENTAL BUR

Name: LEBLOND DIAMOND DENTAL BUR — FDA K833598
Creator: A & M Instruments, Inc.
Keywords: LEBLOND DIAMOND DENTAL BUR, LEBLOND DIAMOND DENTAL BUR, K833598, EJL, FDA

United StatesEJLA & M Instruments, Inc.

Verified

Official record identity

FDA application number: K833598
Decision date: December 29, 1983
Published decision: Substantially Equivalent

Classification

Product code: EJL

Published parties

Applicant: A & M Instruments, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1983-10-12
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3240

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.