Device Classification Name |
Crown And Bridge, Temporary, Resin
|
510(k) Number |
K122025 |
Device Name |
BRIGHTGLASS BRIGHTGLASS M |
Applicant |
KTK MEDICAL SUPPLIES GMBH |
INDUSTRIESTR. 16 |
GERMERING,
DE
D-821110
|
|
Applicant Contact |
THOMAS LOTTERMOSER |
Correspondent |
KTK MEDICAL SUPPLIES GMBH |
INDUSTRIESTR. 16 |
GERMERING,
DE
D-821110
|
|
Correspondent Contact |
THOMAS LOTTERMOSER |
Regulation Number | 872.3770
|
Classification Product Code |
|
Date Received | 07/11/2012 |
Decision Date | 10/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|