Identity
- Trade Name
- iTero Element Barrier Sleeves FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Scanner Sleeve FDA UDI
- Model / Reference
- 209174 FDA UDI
- Description
- Scanner Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020608 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental milling system, CAD/CAM, chairside
iTero Element Barrier Sleeves by Align Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental milling system, CAD/CAM, chairside.
- Shofu Block HC — SHOFU DENTAL CORP. · Class II
- Shofu Block HC — SHOFU DENTAL CORP. · Class II
- DENTSPLY SIRONA® — Shining 3D Tech Co., Ltd. · Class II
- SHOFU DISK — SHOFU DENTAL CORP. · Class II
- TRIOS® — 3shape Trios A/S · Class II
- CS 3500 3D Scanner Collar — CARESTREAM HEALTH, INC. · Class II
- TRIOS® — 3shape Trios A/S · Class II
- KAVO X PRO REUSABLE TIP SUPPORT — PaloDEx Group Oy · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (1)
- FDA UDI 98df57bd-ecbd-450a-af57-ce17f840fe6b 33 fields · synced May 29, 2026