Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K232448 |
Device Name |
FREEPRINT® splintmaster |
Applicant |
Detax GmbH |
Carl-Zeiss-Strasse 4 |
Ettingen,
DE
D-76275
|
|
Applicant Contact |
Markus Stratmann |
Correspondent |
Aclivi, LLC |
3250 Brackley Drive |
Ann Arbor,
MI
48105
|
|
Correspondent Contact |
Chris Brown |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/14/2023 |
Decision Date | 10/12/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|