Any-Zircos— 510(k) K262074
Substantially EquivalentMediclus Co., Ltd.
FDA 510(k) clearance K262074 for Any-Zircos, Substantially Equivalent on 2026-08-21. Applicant: Mediclus Co., Ltd.. Device class: 2.
Summary
Mediclus's Any-Zircos is filed under product code EIH, porcelain powder. The record gives no model numbers or further description.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).
Mediclus filed from Cheongju-Si, South Korea. The decision came 60 calendar days after receipt (June 22 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Mediclus Co., Ltd.
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
Recent devices under product code EIH
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