Device Classification Name |
handpiece, rotary bone cutting
|
510(k) Number |
K171155 |
Device Name |
Surgical Angle Handpiece, Surgical Straight Handpiece |
Applicant |
Nakanishi Inc. |
700 Shimonhinata |
Kanuma-shi,
JP
322-8666
|
|
Applicant Contact |
Kimihiko Satoh |
Correspondent |
Ken Block Consulting |
1201 Richardson Dr. |
Richardson,
TX
75080
|
|
Correspondent Contact |
Belia Juarez |
Regulation Number | 872.4120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/20/2017 |
Decision Date | 11/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|