Dia-X Bond Universal
FDA 510(k) K220804 · DiaDent Group International
510(k) numberK220804
Submission
- Device name
- Dia-X Bond Universal
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- March 18, 2022
- Decision date
- June 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261166 | Dia-CemEMA · Traditional | 07/09/2026SE |
| K261093 | DiafilEBF · Traditional | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | 05/19/2026SE |
| K254112 | Dia-X Sil BiteELW · Traditional | 03/19/2026SE |
| K231552 | Dia-CemEMA · Traditional | 07/28/2023SE |
| K213401 | DIAPLUS UniversalKLE · Traditional | 01/31/2022SE |
| K210421 | Diafil & Diafil CapsuleEBF · Special | 06/28/2021SE |
| K210333 | DiaPasteKIF · Special | 03/25/2021SE |
| K200174 | Dia-Root Bio MtaKIF · Traditional | 09/18/2020SE |
| K200809 | D-Lux+EBZ · Traditional | 08/07/2020SE |
Questions and answers
When was Dia-X Bond Universal cleared by the FDA?
Dia-X Bond Universal (K220804) received a 510(k) decision of Substantially Equivalent on June 15, 2022, 89 days after the submission was received.
What is the product code of K220804?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.