Device Classification Name |
Material, Impression
|
510(k) Number |
K190571 |
Device Name |
StoneBite and StoneBite scan |
Applicant |
Dreve Dentamid GmbH |
Max-Planck-Strasse 31 |
Unna,
DE
59423
|
|
Applicant Contact |
Reiner Altmann |
Correspondent |
BQC Consulting LLC |
24341 Barbados Dr. |
Dana Point,
CA
92629
|
|
Correspondent Contact |
Nevine Erian |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 03/06/2019 |
Decision Date | 11/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|