FDA · official record K802811Substantially Equivalent

MONOJECT ROOT CANAL FILLING MAT. NEEDLE

Name: MONOJECT ROOT CANAL FILLING MAT. NEEDLE — FDA K802811
Creator: Sherwood Medical Co.
Keywords: MONOJECT ROOT CANAL FILLING MAT. NEEDLE, MONOJECT ROOT CANAL FILLING MAT. NEEDLE, K802811, DZM, FDA

United StatesDZMSherwood Medical Co.

Verified

Official record identity

FDA application number: K802811
Decision date: November 24, 1980
Published decision: Substantially Equivalent

Classification

Product code: DZM

Published parties

Applicant: Sherwood Medical Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1980-11-07
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4730

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.