The following data is part of a premarket notification filed by Formlabs Ohio, Inc. with the FDA for Dental Lt Clear V2 Resin.
| Device ID | K222061 |
| 510k Number | K222061 |
| Device Name: | Dental LT Clear V2 Resin |
| Classification | Mouthguard, Prescription |
| Applicant | Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury, OH 43447 |
| Contact | Ritika Sharma |
| Correspondent | Ritika Sharma Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury, OH 43447 |
| Product Code | MQC |
| Subsequent Product Code | DYT |
| Subsequent Product Code | KMY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-13 |
| Decision Date | 2022-11-10 |