Device Classification Name |
x-ray, tomography, computed, dental
|
510(k) Number |
K120948 |
Device Name |
PREXION 3D |
Applicant |
THE YOSHIDA DENTAL MFG. CO., LTD. |
1-3-6 KOTOBASHI, SUMIDA-KU |
TOKYO,
JP
130-8516
|
|
Applicant Contact |
HIDENORI WATANABE |
Correspondent |
THE YOSHIDA DENTAL MFG. CO., LTD. |
1-3-6 KOTOBASHI, SUMIDA-KU |
TOKYO,
JP
130-8516
|
|
Correspondent Contact |
HIDENORI WATANABE |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 03/29/2012 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|