Composite Orthodontic Brackets and Buttons
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251196 FDA 510(k)
- FDA Product Code
- DYW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Composite Orthodontic Brackets and Buttons are classified as plastic orthodontic brackets, designed for use in dental orthodontic treatment. These devices are intended to attach to teeth to facilitate the alignment and movement of dental structures, typically as part of a fixed orthodontic appliance system. Their composite material construction provides durability and bonding compatibility with dental adhesives, ensuring secure placement during treatment.
These brackets and buttons are supplied as single-use, non-sterile devices intended for professional dental use only. They are regulated under FDA 510(k) clearance (K251196) as a Class 2 dental device under product code DYW, with a decision of Substantially Equivalent (SESE). No specific MRI safety or sterility requirements are noted in the regulatory data, and they are not intended for reusable applications. Storage and handling should comply with standard orthodontic device protocols.
Frequently asked questions
What are the Composite Orthodontic Brackets and Buttons used for?
These brackets and buttons are designed for dental orthodontic treatment to attach to teeth and facilitate the alignment and movement of dental structures as part of a fixed orthodontic appliance system. Their composite material ensures durability and compatibility with dental adhesives for secure placement during treatment.
Are the Composite Orthodontic Brackets and Buttons reusable or single-use?
The brackets and buttons are explicitly supplied as single-use devices. They are intended for professional dental use only and are not intended for reuse, even after cleaning or sterilization attempts. This classification aligns with standard orthodontic device protocols.
What regulatory clearance do these brackets and buttons hold?
The Composite Orthodontic Brackets and Buttons are FDA 510(k)-cleared under clearance number K251196. They are classified as a Class 2 dental device under product code DYW, with a decision of Substantially Equivalent (SESE). This clearance confirms their compliance with U.S. regulatory standards for plastic orthodontic brackets.
Are these brackets and buttons sterile?
No, the brackets and buttons are supplied as non-sterile devices. They are intended for professional dental use only, and sterility is not required or implied for this application. Standard orthodontic handling and storage protocols should be followed to maintain cleanliness.
How should these brackets and buttons be stored?
While specific storage instructions are not detailed in the regulatory data, standard orthodontic device protocols should be adhered to. This typically includes keeping the brackets and buttons in a clean, dry environment, protected from contamination, and away from direct sunlight or extreme temperatures. Ensure they are stored in their original packaging until ready for use.
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. Sources consulted: K251196 FDA 510(k) - Composite Orthodontic Brackets and Buttons, Composite Orthodontic Brackets | Medical Device Navigator, Ec Certification Service GmbH FDA 510(k) Products - Latest 2025, Composite Orthodontic Brackets and Buttons 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251196 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EC Certification Service GmbH
Sources (1)
- FDA 510(k) K251196 24 fields · synced Oct 5, 2026