Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K222061 |
Device Name |
Dental LT Clear V2 Resin |
Applicant |
Formlabs Ohio, Inc. |
27800 Lemoyne Rd |
Millbury,
OH
43447
|
|
Applicant Contact |
Ritika Sharma |
Correspondent |
Formlabs Ohio, Inc. |
27800 Lemoyne Rd |
Millbury,
OH
43447
|
|
Correspondent Contact |
Ritika Sharma |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/13/2022 |
Decision Date | 11/10/2022 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|