K241311
- 510(k) number
- K241311
- Device name
- Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
- Applicant
- Bernhard Förster GmbH DE
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2024-08-02
- Date received
- 2024-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241311.pdf
Official FDA record: K241311
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.