Core·it Dual— 510(k) K262982
Substantially EquivalentSpident Co., Ltd.
FDA 510(k) clearance K262982 for Core·it Dual, Substantially Equivalent on 2026-09-21. Applicant: Spident Co., Ltd.. Device class: 2.
Summary
Core·it Dual comes from Spident Co., Ltd. under product code EBF (Material, Tooth Shade, Resin). The record has no detail on the material beyond that name and code.
Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel, and it came in as a Special 510(k). The decision was Substantially Equivalent.
Spident filed from Incheon, South Korea. The decision came 25 calendar days after receipt (August 27 to September 21, 2026).
Clearance details
- Applicant
- Spident Co., Ltd.
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Incheon, KR
Recent devices under product code EBF
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