Any-Cem— 510(k) K254201
Substantially EquivalentMediclus Co., Ltd.
FDA 510(k) clearance K254201 for Any-Cem, Substantially Equivalent on 2026-08-13. Applicant: Mediclus Co., Ltd.. Device class: 2.
Summary
Mediclus's Any-Cem is filed under product code EMA, dental cement. The record gives no model numbers or further description.
Class II, 21 CFR 872.3275. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
Mediclus filed from Cheongju-Si, South Korea. The decision came 227 calendar days after FDA received it (December 29, 2025 to August 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Mediclus Co., Ltd.
- Product code
- Product code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
Recent devices under product code EMA
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