Invisalign Pre-Formed Attachment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222894 FDA 510(k)
- FDA Product Code
- NXC 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 Invisalign Pre-Formed Attachment System is a patient-specific dental device designed for the precise bonding of 3D-printed attachments to teeth. It is classified as a sequential aligner system and serves as an adjunct to orthodontic treatment by enhancing attachment placement for improved alignment and movement of teeth.
This system is supplied as a doctor-prescribed, pre-formed kit containing two sets of attachment positioners per quadrant requiring attachments. It is intended for single-use in a clinical setting and has received FDA 510(k) clearance and MDD authorization. The device is regulated under the classification NXC and is used exclusively in dental practice for orthodontic applications.
Frequently asked questions
What is the Invisalign Pre-Formed Attachment System used for in a clinical setting?
The Invisalign Pre-Formed Attachment System is designed as an adjunct to orthodontic treatment to enhance the precision of attachment placement on teeth. It aids in improving alignment and movement during sequential aligner therapy by providing pre-formed attachments that bond directly to teeth, ensuring consistent and accurate results for orthodontic adjustments.
How is the Invisalign Pre-Formed Attachment System supplied, and is it meant for single-use?
The system is supplied as a doctor-prescribed, pre-formed kit containing two sets of attachment positioners per quadrant requiring attachments. It is explicitly intended for single-use in a clinical setting, meaning each kit is designed for one-time use with a patient to ensure sterility and safety.
What regulatory pathways has the Invisalign Pre-Formed Attachment System followed, and what does that mean for its use?
The device has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. This means it is legally authorized for use in dental practices in the U.S. and European markets, adhering to the classification NXC for orthodontic applications. The clearance indicates it is deemed substantially equivalent to a predicate device already on the market.
Does the Invisalign Pre-Formed Attachment System require any special handling or storage conditions?
While the device data does not specify storage conditions, the system is designed for clinical use and is supplied as a sterile, single-use kit. Clinicians should follow standard protocols for handling orthodontic attachments, ensuring the kit remains uncontaminated until use. Proper storage in a clean, dry environment is recommended to maintain integrity until use.
Is the Invisalign Pre-Formed Attachment System compatible with all types of sequential aligner systems?
The system is specifically designed as part of the Invisalign sequential aligner system, which is a patient-specific orthodontic treatment. While it is intended to enhance attachment placement within this system, compatibility is limited to the Invisalign framework and its associated protocols for optimal results. It is not meant for use with other aligner systems.
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, Invisalign Pre-Formed Attachment System 5000 The… - FDA.report, Invisalign®️ Anwendersuche| Einen zertifizierten Invisalign …, Align Technology, Inc. 9030 Invisalign Pre-Formed Attachment System ...
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 | K222894 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (2)
- FDA 510(k) K222894 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026