K230091
- 510(k) number
- K230091
- Device name
- THE Cover
- Applicant
- Purgo Biologics, Inc. KR
- Product code
- NPL — Barrier, Animal Source, Intraoral
- Decision date
- 2023-10-06
- Date received
- 2023-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230091.pdf
Official FDA record: K230091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.