ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED


Device Classification Name

implant, endosseous, root-form

510(k) Number K024111
Device Name ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
Original Applicant
ASTRA TECH, INC.
96 west main st.
p.o. box 809
northborough, 
MA 
01532

Original Contact bruce r manning
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 12/13/2002
Decision Date 06/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No