Any-Etch— 510(k) K260485
Substantially EquivalentMediclus Co., Ltd.
FDA 510(k) clearance K260485 for Any-Etch, Substantially Equivalent on 2026-05-14. Applicant: Mediclus Co., Ltd.. Device class: 2.
Summary
Mediclus's Any-Etch is filed under KLE, resin tooth bonding agents.
Class II, 21 CFR 872.3200. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Mediclus filed from Cheongju-Si, South Korea. The decision came 90 calendar days after receipt (February 13 to May 14, 2026).
Clearance details
- Applicant
- Mediclus Co., Ltd.
- Product code
- Product code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
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