DIAFIL & DIAFIL Capsule
FDA 510(k) K192510 · DiaDent Group International
510(k) numberK192510
Submission
- Device name
- DIAFIL & DIAFIL Capsule
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- September 12, 2019
- Decision date
- March 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K254112 | Dia-X Sil BiteELW · Traditional | 03/19/2026SE |
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| K213401 | DIAPLUS UniversalKLE · Traditional | 01/31/2022SE |
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| K210333 | DiaPasteKIF · Special | 03/25/2021SE |
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Questions and answers
When was DIAFIL & DIAFIL Capsule cleared by the FDA?
DIAFIL & DIAFIL Capsule (K192510) received a 510(k) decision of Substantially Equivalent on March 20, 2020, 190 days after the submission was received.
What is the product code of K192510?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.