SCREWLINE


Device Classification Name

implant, endosseous, root-form

510(k) Number K022425
Device Name SCREWLINE
Original Applicant
ALTATEC BIOTECHNOLOGIES N.A., INC.
9229 cranford dr.
potomac, 
MD 
20854

Original Contact robert j slomoff
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 07/24/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No