FDA · official record K954012Substantially Equivalent

DISPOSABLE PROPHY HANDPIECE

Name: DISPOSABLE PROPHY HANDPIECE — FDA K954012
Creator: Denticator Intl., Inc.
Keywords: DISPOSABLE PROPHY HANDPIECE, DISPOSABLE PROPHY HANDPIECE, K954012, EFB, FDA

United StatesEFBDenticator Intl., Inc.

Verified

Official record identity

FDA application number: K954012
Decision date: November 08, 1995
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Denticator Intl., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-08-25
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.