510(k) clearance
OSSIX Plus
- 510(k) number
- K262415
- Applicant
- Datum Dental, Ltd.
- Decision date
- Oct 29, 2026
- Date received
- Jul 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NPL
- Device type
- Barrier, Animal Source, Intraoral
- Device class
- Class II
- Regulation
- 21 CFR 872.3930
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Yavne Centra, IL