Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K221022 |
Device Name |
NextDent Ortho Flex |
Applicant |
Vertex-Dental BV |
Centurionbaan 190 |
Soesterberg,
NL
3769AV
|
|
Applicant Contact |
Connie Peterse-van der Koppel |
Correspondent |
Qserve Group US Inc. |
7949 Beaumont Green East Drive |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Patsy J. Trisler |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/06/2022 |
Decision Date | 10/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|