LION SE ONE STEP ORTHODONTIC ADHESIVE


Device Classification Name

adhesive, bracket and tooth conditioner, resin

510(k) Number K080445
Device Name LION SE ONE STEP ORTHODONTIC ADHESIVE
Applicant
CLASSONE ORTHODONTICS, INC.
5064 50th st.
lubbock, 
TX 
79414

Applicant Contact judy ribordy
Correspondent
CLASSONE ORTHODONTICS, INC.
5064 50th st.
lubbock, 
TX 
79414

Correspodent Contact judy ribordy
Regulation Number 872.3750
Classification Product Code
DYH  
Date Received 02/19/2008
Decision Date 07/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No