RMO PLASMA CURING LIGHT


Device Classification Name

activator, ultraviolet, for polymerization

510(k) Number K024374
Device Name RMO PLASMA CURING LIGHT
Original Applicant
LOKKI LASERS MEDICAUX
344 annabelle point rd.
centerville, 
MA 
02632 -2402

Original Contact hillard w welch
Regulation Number 872.6070
Classification Product Code
EBZ  
Date Received 12/31/2002
Decision Date 03/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No