FDA · official record K020884Substantially Equivalent

EXCELLITE LIGHT CURE UNIT

Name: EXCELLITE LIGHT CURE UNIT — FDA K020884
Creator: Rolence Ent., Inc.
Keywords: EXCELLITE LIGHT CURE UNIT, EXCELLITE LIGHT CURE UNIT, K020884, EBZ, FDA

United StatesEBZRolence Ent., Inc.

Verified

Official record identity

FDA application number: K020884
Decision date: June 12, 2002
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Rolence Ent., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-03-18
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.