SWISSPLANT DENTAL IMPLANT SYSTEM


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K081396
Device Name SWISSPLANT DENTAL IMPLANT SYSTEM
Applicant
IMPLANT DIRECT LLC
27030 malibu hills rd.
calabasas hills, 
CA 
91301

Applicant Contact thomas gottenbos
Correspondent
IMPLANT DIRECT LLC
27030 malibu hills rd.
calabasas hills, 
CA 
91301

Correspodent Contact thomas gottenbos
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 05/19/2008
Decision Date 01/14/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No