K232087
- 510(k) number
- K232087
- Device name
- Dental LT Comfort Resin
- Applicant
- Formlabs Ohio, Inc. OH · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-02-16
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K232087.pdf
Official FDA record: K232087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.