510(k) clearance
LiteSet Trays
- 510(k) number
- K253988
- Applicant
- Nobel Biocare AB
- Decision date
- Sep 8, 2026
- Date received
- Dec 12, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KCT
- Device type
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II
- Regulation
- 21 CFR 880.6850
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Goteborg, SE