FDA · official record K041372Substantially Equivalent

SMARTLITE PS PEN-STYLE LED CURING LIGHT

Name: SMARTLITE PS PEN-STYLE LED CURING LIGHT — FDA K041372
Creator: Dentsply International
Keywords: SMARTLITE PS PEN-STYLE LED CURING LIGHT, SMARTLITE PS PEN-STYLE LED CURING LIGHT, K041372, EBZ, FDA

United StatesEBZDentsply International

Verified

Official record identity

FDA application number: K041372
Decision date: June 24, 2004
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Dentsply International

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2004-05-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.