BONART’S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES


Device Classification Name

drill, bone, powered

510(k) Number K080761
Device Name BONART’S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
Applicant
BONART CO. LTD.
398 s. lemon creek dr.
ste. l
walnut, 
CA 
91789

Applicant Contact eric l ong
Correspondent
BONART CO. LTD.
398 s. lemon creek dr.
ste. l
walnut, 
CA 
91789

Correspodent Contact eric l ong
Regulation Number 872.4120
Classification Product Code
DZI  
Date Received 03/18/2008
Decision Date 08/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No