K250456
- 510(k) number
- K250456
- Device name
- Dentemp Pro-Comfort Dental Guard
- Applicant
- Doc Brands, Inc. PA · US
- Product code
- OBR — Mouthguard, Over-The-Counter
- Decision date
- 2025-05-19
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250456.pdf
Official FDA record: K250456
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.