PSM LOMAS / BENEFIT SCREWS


Device Classification Name

implant, endosseous, orthodontic

510(k) Number K110392
Device Name PSM LOMAS / BENEFIT SCREWS
Applicant
PSM MEDICAL SOLUTIONS
schwarzwaldstrasse 5
tuttlingen bw, 

DE

78532

Applicant Contact andrea pecsi
Correspondent
PSM MEDICAL SOLUTIONS
schwarzwaldstrasse 5
tuttlingen bw, 

DE

78532

Correspodent Contact andrea pecsi
Regulation Number 872.3640
Classification Product Code
OAT  
Date Received 02/11/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No