Dia-X Bond Universal
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DIA-X BOND EUDAMED
- Device Name
- DIA-X BOND EUDAMED
- Model / Reference
- DIA-X BOND 5ml EUDAMEDA2001-2101EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806383586634 EUDAMED
- Basic UDI-DI
- B-08806383586634 EUDAMED
- 510(k) Number
- K220804 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Dia-X Bond Universal is a Tooth Bonding Agent, Resin, classified under dental adhesives. It is designed to chemically bond dental restorative materials to tooth structure, providing durable adhesion for composite resins, cements, and other dental restorations. This agent facilitates a strong, long-lasting bond essential for maintaining the integrity of dental repairs and restorative procedures.
This resin bonding agent is supplied as a single-use, non-sterile product intended for use in dental clinics and offices. It is classified as a Class II medical device under FDA regulations (21 CFR 872.3200) and has received FDA 510K clearance and MDD compliance. The product is packaged for individual applications and must be stored according to manufacturer instructions to preserve its efficacy. No MRI safety information is specified.
Frequently asked questions
What is the Dia-X Bond Universal used for in dental procedures?
The Dia-X Bond Universal is a tooth bonding agent designed to chemically bond dental restorative materials—such as composite resins and cements—to tooth structure. It ensures durable adhesion, which is critical for maintaining the integrity of dental repairs, fillings, and restorations during routine procedures.
Is the Dia-X Bond Universal sterile, and how should it be stored?
The Dia-X Bond Universal is supplied as a non-sterile product, intended for single-use in dental clinics. To preserve its efficacy, it must be stored according to the manufacturer’s instructions, which are provided with the packaging. Proper storage conditions help maintain the resin’s performance for bonding applications.
Are there multiple sizes or models of the Dia-X Bond Universal, or is it a single formulation?
The provided data does not specify multiple sizes or models for the Dia-X Bond Universal. It is described as a single-use resin bonding agent, implying a standardized formulation for universal dental adhesive applications. For exact packaging details, refer to the manufacturer’s labeling.
What regulatory pathways has the Dia-X Bond Universal followed, and how does that affect its use?
The Dia-X Bond Universal has received FDA 510(k) clearance and complies with the MDD (Medical Device Directive). This classification confirms it is a Class II medical device under FDA regulations (21 CFR 872.3200), meaning it has undergone premarket review to ensure safety and effectiveness for its intended dental adhesive use. Clinicians can rely on its regulatory status as evidence of compliance with dental industry standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220804 | Class II | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
Sources (2)
- FDA 510(k) K220804 24 fields · synced Sep 18, 2026
- EUDAMED b19f9734-08d3-4d1d-aeac-6af5d281dd34 61 fields · synced Jul 31, 2026