510(k) clearances

Dia-X Sil Light Body

DiaDent Group International · Dental

K254152Substantially EquivalentTraditionalELW
Open FDA's page for this record
Third party flag
N
City
Cheongju-Si
Advisory committee description
Dental
Address 1
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Statement or summary
Summary
Product code
ELW
Zip code
28186
Applicant
DiaDent Group International
Decision date
2026-09-16
Decision code
SESE
Country code
KR
Device name
Dia-X Sil Light Body
Advisory committee
DE
Contact
Jin An
K number
K254152
Date received
2025-12-22
Review advisory committee
DE
Postal code
28186
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Material, Impression
Medical specialty description
Dental
Regulation number
872.3660
Device class
2
Registration number
3018507299, 3010864832, 3014683120, 2523320, 3006316962, 3030268763, 8021059, 3015332784, 3023401336, 2515379, 3032911850, 3032435508, 3011944170, 3008922120, 3026400121, 3031886796, 2024980, 2081322, 9613375, 2126683, 9613953, 3004793856, 3004158247, 3003775534, 2431069, 3010664129, 4565, 3003941201, 3014615644, 1530561, 3010407924, 3043226252, 3013012934, 3008895253, 3005628474, 3032312561, 9614977, 2087259, 3005558160, 3015143007 +110 more
FEI number
3018507299, 3003136707, 3014683120, 2523320, 3006316962, 3030268763, 3002806620, 3015332784, 3023401336, 2515379, 3032911850, 3010862763, 3032435508, 3011944170, 3008922120, 3026400121, 3031886796, 3008875470, 3000719964, 2081322, 2126683, 3002808289, 3004793856, 3004158247, 3003775534, 2431069, 3010664129, 4565, 3003941201, 3014615644, 3010407924, 3002807052, 3002806930, 3043226252, 3013012934, 3003381355, 3005628474, 3032312561, 3002807166, 3005558160 +110 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.