K230592
- 510(k) number
- K230592
- Device name
- LuxCreo Dental Night Guard Resin
- Applicant
- LuxCreo, Inc. CA · US
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-01-18
- Date received
- 2023-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K230592
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.