FDA · official record K033812Substantially Equivalent

SIROAIR L AIR SCALER

Name: SIROAIR L AIR SCALER — FDA K033812
Creator: Sirona Dental Systems GmbH
Keywords: SIROAIR L AIR SCALER, SIROAIR L AIR SCALER, K033812, EFB, FDA

United StatesEFBSirona Dental Systems GmbH

Verified

Official record identity

FDA application number: K033812
Decision date: February 23, 2004
Published decision: Substantially Equivalent

Classification

Product code: EFB

Published parties

Applicant: Sirona Dental Systems GmbH

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-12-09
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.