Identity
- Trade Name
- Packed 5D Plus Lite Scanning Unit, RMA FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Wand RMAs FDA UDI
- Model / Reference
- 212203 FDA UDI
- Description
- Wand RMAs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021025 FDA UDI
- 510(k) Number
- K193659 FDA UDI
- FDA Product Code
- NTK FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1745 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental milling system, CAD/CAM, chairside
Packed 5D Plus Lite Scanning Unit, RMA by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental milling system, CAD/CAM, chairside.
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Cleared under the same submission
K193659 also covers:
- DOA Kit, 5D US Plus — Align Technology, Inc.
- DOA Kit, Element 5D Plus Lite — Align Technology, Inc.
- Packed 5D Plus US Scanning Unit, RMA — Align Technology, Inc.
- iTero 5D Scanning Unit — Align Technology, Inc.
- iTero Element 5D LC Upgrade, Kit US — Align Technology, Inc.
- iTero Element 5D Plus Ready US Cart configuration — Align Technology, Inc.
- iTero Element 5D Plus Ready US Mobile configuration — Align Technology, Inc.
- iTero Element 5D Plus US cart configuration — Align Technology, Inc.
- iTero Element 5D Plus US mobile configuration — Align Technology, Inc.
- iTero Element 5D Plus US wand upgrade — Align Technology, Inc.
- iTero Element 5D Plus upgrade cart configuration — Align Technology, Inc.
- iTero Element 5D Plus upgrade mobile configuration — Align Technology, Inc.
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 c0e19d82-9cd6-4578-a2f4-0775c0f6b121 34 fields · synced Jun 6, 2026