BrackFix
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- BrackFix EUDAMEDFDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- BrackFix EUDAMED
- Model / Reference
- 1207 EUDAMEDFDA UDI1205 EUDAMEDFDA UDIsyringe EUDAMED
Identifiers
- Primary DI / UDI-DI
- E22112071 EUDAMEDFDA UDIE22112051 EUDAMEDFDA UDI
- Basic UDI-DI
- B-E22112071 EUDAMEDB-E22112051 EUDAMED
- 510(k) Number
- FDA Product Code
- DYH FDA 510(k)FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The BrackFix is classified as an Adhesive, Bracket and Tooth Conditioner, a dental device designed to prepare tooth surfaces and facilitate the bonding of orthodontic brackets. It acts as a primer and conditioner to enhance adhesion between brackets and enamel, ensuring a durable and stable attachment for orthodontic treatment.
This device is supplied as a single-use, non-sterile resin-based system intended for use in dental offices. It is regulated under the Medical Device Directive (MDD) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Storage requires protection from moisture and extreme temperatures, and proper disposal follows standard dental waste protocols.
Frequently asked questions
What is the primary purpose of the BrackFix adhesive system in orthodontic treatment?
The BrackFix is designed as an Adhesive, Bracket and Tooth Conditioner to prepare tooth surfaces for orthodontic brackets. It acts as a primer and conditioner, enhancing adhesion between brackets and enamel to ensure a durable and stable bond during treatment. This helps improve the longevity of bracket placement, reducing the risk of premature detachment.
Is the BrackFix system single-use or reusable, and what storage requirements apply?
The BrackFix is explicitly labeled as a single-use resin-based system. Since it is non-sterile, it must be stored in a way that protects it from moisture and extreme temperatures to maintain its integrity. Always follow standard dental office protocols for storage and disposal, adhering to local regulations for dental waste.
What regulatory pathways has the BrackFix undergone, and where is it manufactured?
The BrackFix has received FDA 510(k) clearance under the Traditional pathway, determined to be substantially equivalent to a predicate device. It is also compliant with the Medical Device Directive (MDD) in Europe. The manufacturer, VOCO GmbH, is based in Cuxhaven, Germany, with contact details available through their official channels.
Does the BrackFix come in multiple sizes or models, and how would I identify the correct one for my practice?
The provided data lists multiple FEI numbers and registration numbers, indicating the BrackFix is available in various configurations or batch identifiers (e.g., 3010862763, 1815540, etc.). These likely correspond to different product variants or lot numbers rather than distinct physical sizes. For precise sizing or model selection, consult the manufacturer’s catalog or technical documentation, as the exact dimensions or variations aren’t detailed in the regulatory data.
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 | K183147 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (5)
- FDA 510(k) K183147 24 fields · synced Oct 6, 2026
- FDA UDI b58fdf26-4950-4402-956d-fe7f72926b85 34 fields · synced May 30, 2026
- FDA UDI 7c9e6c1e-1c20-4e2e-8ca3-72861b687609 34 fields · synced May 30, 2026
- EUDAMED 92ea18f8-dc00-4ac1-9151-539f977dc494 61 fields · synced Jul 10, 2026
- EUDAMED c68d064c-d0c4-4cce-918d-a657b1045617 61 fields · synced Jul 13, 2026