FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DiaPlus
K Number: K192392
·
Decision May 26, 2020
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
21
Review Days
266
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Basic Information
- Device Name
- DiaPlus
- K Number
- K192392
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaDent Group International
- Date Received
- September 3, 2019
- Decision Date
- May 26, 2020
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by DiaDent Group International
| K Number | Device Name | ||
|---|---|---|---|
| K261093 | DIAFIL | Jun 2, 2026 | Substantially Equivalent |
| 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 |