FDA · official record K973667Substantially Equivalent

VITAPEX PRE-LOADED DENTAL SYRINGE

Name: VITAPEX PRE-LOADED DENTAL SYRINGE — FDA K973667
Creator: Neodental Chemical Products Co., Ltd.
Keywords: VITAPEX PRE-LOADED DENTAL SYRINGE, VITAPEX PRE-LOADED DENTAL SYRINGE, K973667, KIF, FDA

United StatesKIFNeodental Chemical Products Co., Ltd.

Verified

Official record identity

FDA application number: K973667
Decision date: November 06, 1997
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Neodental Chemical Products Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-09-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.