510(k) K232087
K232087 is an FDA 510(k) premarket notification submitted by Formlabs Ohio, Inc. for the device "Dental LT Comfort Resin". The FDA issued a decision of Substantially Equivalent on February 16, 2024. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Formlabs Ohio, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2024
- Date Received
- July 13, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type