I-MINI DENTAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K080115
Device Name I-MINI DENTAL IMPLANT
Applicant
OCO BIOMEDICAL
21525 ridgetop circle
suite 240
sterling, 
VA 
20166

Applicant Contact kevin walls
Correspondent
OCO BIOMEDICAL
21525 ridgetop circle
suite 240
sterling, 
VA 
20166

Correspodent Contact kevin walls
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 01/16/2008
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No