FDA · official record K952448Substantially Equivalent

3.3MM ACCESSORIES

Name: 3.3MM ACCESSORIES — FDA K952448
Creator: Nobelpharma USA, Inc.
Keywords: 3.3MM ACCESSORIES, 3.3MM ACCESSORIES, K952448, DZE, FDA

United StatesDZENobelpharma USA, Inc.

Verified

Official record identity

FDA application number: K952448
Decision date: June 20, 1995
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Nobelpharma USA, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-05-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.