Identity
- Trade Name
- Invisalign Pre-Formed Attachment System FDA UDI
- Generic Name
- Orthodontic aligner auxiliary attachment kit FDA UDI
- Device Name
- The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attachments onto the patient’s teeth. The pre-formed attachment system contains two sets of attachment positioners for each quadrant that requires attachments. FDA UDI
- Model / Reference
- 5000 FDA UDI
- Description
- The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attachments onto the patient’s teeth. The pre-formed attachment system contains two sets of attachment positioners for each quadrant that requires attachments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063022800 FDA UDI
- 510(k) Number
- K222894 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic aligner auxiliary attachment kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic aligner auxiliary attachment kit
Invisalign Pre-Formed Attachment System by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic aligner auxiliary attachment kit.
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Cleared under the same submission
K222894 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (1)
- FDA UDI 61f97b7a-4bed-4f63-ab22-358fe837c772 34 fields · synced Jun 8, 2026