Device Classification Name |
Crown And Bridge, Temporary, Resin
|
510(k) Number |
K112967 |
Device Name |
PMMA CAD/CAM DISC |
Applicant |
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
VOLCJA DRAGA 42 |
VOLCJA DRAGA,
SI
5293
|
|
Applicant Contact |
JANJA LIPUSCEK |
Correspondent |
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
VOLCJA DRAGA 42 |
VOLCJA DRAGA,
SI
5293
|
|
Correspondent Contact |
JANJA LIPUSCEK |
Regulation Number | 872.3770
|
Classification Product Code |
|
Date Received | 10/05/2011 |
Decision Date | 08/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|