K243654
- 510(k) number
- K243654
- Device name
- DentalJect
- Applicant
- Vapocoolshot, Inc. FL · US
- Product code
- MLY — Vapocoolant Device
- Decision date
- 2025-05-30
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243654.pdf
Official FDA record: K243654
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.