DIAPLUS Universal
FDA 510(k) K213401 · DiaDent Group International
510(k) numberK213401
Submission
- Device name
- DIAPLUS Universal
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- October 18, 2021
- Decision date
- January 31, 2022
- 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 |
| K231552 | Dia-CemEMA · Traditional | 07/28/2023SE |
| K220804 | Dia-X Bond UniversalKLE · Special | 06/15/2022SE |
| K210421 | Diafil & Diafil CapsuleEBF · Special | 06/28/2021SE |
| K210333 | DiaPasteKIF · Special | 03/25/2021SE |
| K200174 | Dia-Root Bio MtaKIF · Traditional | 09/18/2020SE |
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Questions and answers
When was DIAPLUS Universal cleared by the FDA?
DIAPLUS Universal (K213401) received a 510(k) decision of Substantially Equivalent on January 31, 2022, 105 days after the submission was received.
What is the product code of K213401?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.