K221851
- 510(k) number
- K221851
- Device name
- Lumina-PTFE Titanium
- Applicant
- Criteria Industria E Comercio DE Produtos Medicinais BR
- Product code
- NPK — Barrier, Synthetic, Intraoral
- Decision date
- 2023-12-08
- Date received
- 2022-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K221851.pdf
Official FDA record: K221851
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.