Dia-X Sil Bite— 510(k) K254112

Substantially Equivalent

DiaDent Group International

FDA 510(k) clearance K254112 for Dia-X Sil Bite, Substantially Equivalent on 2026-03-19. Applicant: DiaDent Group International.

Clearance details

Applicant: DiaDent Group International
Product code: Code ELW
Advisory panel: Dental
Date received: 2025-12-19
Decision date: 2026-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

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Data sourced from openFDA. This site is unofficial and independent of the FDA.