LiteSet Trays— 510(k) K253988
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K253988 for LiteSet Trays, Substantially Equivalent on 2026-09-08. Applicant: Nobel Biocare AB. Device class: 2.
Summary
LiteSet Trays from Nobel Biocare are filed under KCT, sterilization wrap containers, trays, cassettes, and other accessories. The record doesn't describe the trays' size, material, or contents.
Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Nobel Biocare filed from Goteborg, Sweden. The decision came 270 calendar days after FDA received it (December 12, 2025 to September 8, 2026).
Clearance details
- Applicant
- Nobel Biocare AB
- Product code
- Product code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
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