SPI SYSTEM DENTAL IMPLANTS


Device Classification Name

implant, endosseous, root-form

510(k) Number K072649
Device Name SPI SYSTEM DENTAL IMPLANTS
Applicant
THOMMEN MEDICAL, AG
11234 el camino real, ste. 200
san diego, 
CA 
92130

Applicant Contact linda k schulz
Correspondent
THOMMEN MEDICAL, AG
11234 el camino real, ste. 200
san diego, 
CA 
92130

Correspodent Contact linda k schulz
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/19/2007
Decision Date 12/06/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No