Identity
- Trade Name
- Attachment Template FDA UDI
- Generic Name
- Orthodontic resin positioning tray FDA UDI
- Device Name
- The Invisalign™ Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan. FDA UDI
- Model / Reference
- 100012 FDA UDI
- Description
- The Invisalign™ Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063022169 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic resin positioning tray 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 resin positioning tray
Attachment Template by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e1053043-702d-42c6-84ee-49adaac422c4 34 fields · synced May 30, 2026