FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DIAFIL
K Number: K261093
·
Decision Jun 2, 2026
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
21
Review Days
61
Basic Information
- Device Name
- DIAFIL
- K Number
- K261093
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaDent Group International
- Date Received
- April 2, 2026
- Decision Date
- June 2, 2026
- Product Code
- EBF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by DiaDent Group International
| K Number | Device Name | ||
|---|---|---|---|
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | May 19, 2026 | Substantially Equivalent |
| K254112 | Dia-X Sil Bite | Mar 19, 2026 | Substantially Equivalent |
| K231552 | Dia-Cem | Jul 28, 2023 | Substantially Equivalent |
| K220804 | Dia-X Bond Universal | Jun 15, 2022 | Substantially Equivalent |
| K213401 | DIAPLUS Universal | Jan 31, 2022 | Substantially Equivalent |
| K210421 | Diafil & Diafil Capsule | Jun 28, 2021 | Substantially Equivalent |
| K210333 | DiaPaste | Mar 25, 2021 | Substantially Equivalent |
| K200174 | DIA-ROOT BIO MTA | Sep 18, 2020 | Substantially Equivalent |
| K200809 | D-LUX+ | Aug 7, 2020 | Substantially Equivalent |
| K200175 | DIA-ROOT BIO Sealer | Jun 25, 2020 | Substantially Equivalent |