OSI O-BALL ABUTMENT HEAD IMPLANTS


Device Classification Name

implant, endosseous, root-form

510(k) Number K110548
Device Name OSI O-BALL ABUTMENT HEAD IMPLANTS
Applicant
JUELL DENTAL
2401 n commerce
ardmore, 
OK 
73401

Applicant Contact angela blackwell
Correspondent
JUELL DENTAL
2401 n commerce
ardmore, 
OK 
73401

Correspodent Contact angela blackwell
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 02/25/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No