MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K021833
Device Name MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
Original Applicant
BLUE SKY BIO
5455 n. sheridan rd.
#3608
chicago, 
IL 
60640

Original Contact albert zickmann
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 06/04/2002
Decision Date 06/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No