FLASH-LITE II LED DENTAL CURING LIGHT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K023748
Device Name FLASH-LITE II LED DENTAL CURING LIGHT
Original Applicant
DISCUS DENTAL, INC.
8550 higuera st.
culver city, 
CA 
90232 -2522

Original Contact gary l hollar
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 11/08/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No