Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K211804 |
Device Name |
3Delta Crown |
Applicant |
DeltaMed GmbH |
Raiffeisenstrasse 8a |
Friedberg,
DE
61169
|
|
Applicant Contact |
Michael Zimmermann |
Correspondent |
Cosmedent Inc. |
401 North Michigan Ave. Suite 2500 |
Chicago,
IL
60611
|
|
Correspondent Contact |
Gary Chuven |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 06/11/2021 |
Decision Date | 12/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|