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Invisalign System with Mandibular advancement - precision wings
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Invisalign System with Mandibular advancement - precision wings FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- The Invisalign System with Mandibular advancement - precision wings is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. FDA UDI
- Model / Reference
- 222716 FDA UDI
- Description
- The Invisalign System with Mandibular advancement - precision wings is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063022152 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic progressive aligner 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
No
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 progressive aligner
Invisalign System with Mandibular advancement - precision wings by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K181739 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 0dde2957-b893-425f-9ae9-3c95ce297137 34 fields · synced May 30, 2026