FDA · official record K861681Substantially Equivalent

DENTIMEDIC DENTAL EMERGENCY KIT

Name: DENTIMEDIC DENTAL EMERGENCY KIT — FDA K861681
Creator: Dentimedic
Keywords: DENTIMEDIC DENTAL EMERGENCY KIT, DENTIMEDIC DENTAL EMERGENCY KIT, K861681, EMB, FDA

United StatesEMBDentimedic

Verified

Official record identity

FDA application number: K861681
Decision date: September 23, 1986
Published decision: Substantially Equivalent

Classification

Product code: EMB

Published parties

Applicant: Dentimedic

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1986-05-01
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3275

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.