Device Classification Name |
Mouthguard, Prescription
|
510(k) Number |
K214102 |
Device Name |
Glidewell Appliance Resin, Hard/Soft |
Applicant |
Prismatik Dentalcraft, Inc. |
2144 Michelson Drive |
Irvine,
CA
92612
|
|
Applicant Contact |
Jiahe Li |
Correspondent |
Prismatik Dentalcraft, Inc. |
2144 Michelson Drive |
Irvine,
CA
92612
|
|
Correspondent Contact |
Jiahe Li |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/2021 |
Decision Date | 02/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|