DIA-CEM— 510(k) K261166
Substantially EquivalentDiaDent Group International
FDA 510(k) clearance K261166 for DIA-CEM, Substantially Equivalent on 2026-07-09. Applicant: DiaDent Group International. Device class: 2.
Summary
DiaDent Group International's DIA-CEM is filed under EMA, dental cements. The record doesn't give the cement's composition.
Class II, 21 CFR 872.3275. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
DiaDent filed from Cheongju-si, South Korea. The decision came 91 calendar days after FDA received it (April 9 to July 9, 2026).
Clearance details
- Applicant
- DiaDent Group International
- 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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