Dia-X Sil Bite— 510(k) K254112
Substantially EquivalentDiaDent Group International
FDA 510(k) clearance K254112 for Dia-X Sil Bite, Substantially Equivalent on 2026-03-19. Applicant: DiaDent Group International. Device class: 2.
Clearance details
- Applicant
- DiaDent Group International
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheongju-Si, KR
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