Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K143071 |
Device Name |
Nacera Pearl |
Applicant |
DOCERAM MEDICAL CERAMICS GMBH |
HESSLINGSWEG 65-67 |
DORTMUND, NRW,
DE
D-44309
|
|
Applicant Contact |
Stefan Drude |
Correspondent |
DOCERAM MEDICAL CERAMICS GMBH |
HESSLINGSWEG 65-67 |
DORTMUND, NRW,
DE
D-44309
|
|
Correspondent Contact |
Stefan Drude |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 10/27/2014 |
Decision Date | 06/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|