Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K231793 |
Device Name |
RODIN 3D Resin SPLINT, Hard/Flex |
Applicant |
Belport Company, Inc., Gingi-Pak |
4825 Calle Alto |
Camarillo,
CA
93012
|
|
Applicant Contact |
Jingtian Peng |
Correspondent |
Belport Company, Inc., Gingi-Pak |
4825 Calle Alto |
Camarillo,
CA
93012
|
|
Correspondent Contact |
Jingtian Peng |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/20/2023 |
Decision Date | 03/26/2024 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|