Invisalign Specifix Attachment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Invisalign Specifix Attachment System EUDAMED
- Device Name
- Invisalign Specifix Attachment System EUDAMED
- Model / Reference
- 5036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023777 EUDAMED
- Basic UDI-DI
- 081606302Specifix8W EUDAMED
- 510(k) Number
- K252870 FDA 510(k)
- FDA Product Code
- NXC FDA 510(k)
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 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
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Invisalign Specifix Attachment System is a dental device classified as an Orthodontic Plastic Bracket (Regulation Number: 21 CFR 872.5470). It is designed as an attachment system for use with sequential aligners, providing precise bonding sites to enhance the effectiveness of orthodontic treatment by improving alignment control during tooth movement.
This system is supplied as a reusable, non-sterile component intended for use in dental offices. It is regulated under the FDA 510K and MDR frameworks, with a classification of Class II (Product Code: NXC). The attachments are engineered to bond directly to teeth, ensuring secure placement for sequential aligner therapy. No specific MRI safety or sterility requirements are noted in the regulatory data.
Frequently asked questions
What is the primary purpose of the Invisalign Specifix Attachment System in orthodontic treatment?
The Invisalign Specifix Attachment System is designed to provide precise bonding sites for sequential aligners during orthodontic treatment. These attachments enhance alignment control by ensuring secure placement on teeth, which improves the effectiveness and predictability of tooth movement throughout the treatment process.
Is the Invisalign Specifix Attachment System intended for single-use or reusable applications in a dental office?
The system is explicitly supplied as a reusable component for use in dental offices. Since it is not labeled as sterile and no sterility requirements are noted, it must be cleaned and prepared for reuse between patients, adhering to standard dental office protocols for reusable orthodontic attachments.
How is the regulatory status of this device determined, and what classification does it fall under?
The Invisalign Specifix Attachment System is classified as a Class II medical device under the FDA’s 510(k) pathway and the EU’s MDR framework. It is categorized under the product code NXC (Orthodontic Plastic Bracket) and is determined to be *substantially equivalent* to a predicate device, as indicated by the SESE decision code. This classification reflects its role in enhancing precision during orthodontic treatment.
Are there any special handling or storage requirements for the Invisalign Specifix Attachment System?
The system is non-sterile and reusable, so it should be stored in a clean, dry environment to prevent contamination between uses. Since it is not intended for direct patient contact beyond bonding to teeth, standard dental office protocols for reusable orthodontic components should be followed, including proper cleaning and sterilization procedures before reuse.
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: Wie funktioniert das Invisalign System | Invisalign Zahnspangen, The Impact of Invisalign Specifix Attachment System on Orthodontic ..., Invisalign®️ Anwendersuche| Einen zertifizierten Invisalign …, PDF Align Technology, Inc. Niya Su Sr. Manager, Regulatory Affairs 2820 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252870 | Class II | Active |
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Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (2)
- FDA 510(k) K252870 24 fields · synced Sep 18, 2026
- EUDAMED 468c1cd9-db25-4e61-a5be-98ec1fd1ea73 61 fields · synced Jul 19, 2026