Identity
- Trade Name
- Real Arch FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations. FDA UDI
- Model / Reference
- Real Arch FDA UDI
- Description
- Real Arch is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues.The Real Arch is composed of a hand-piece, power hub, adapter and usb3.0 cable. The system produces 3D scans for use in computer- assisted design and manufacturing of dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800005200182 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Intraoral optical scanning system 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoral optical scanning system
Real Arch by Hdx Will Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral optical scanning system.
- TRIOS 5 — 3shape Trios A/S · Class II
- Primescan 2 — Sirona Dental Systems GmbH · Class II
- TRIOS® 4 — 3shape Trios A/S · Class II
- TRIOS® 4 — 3shape Trios A/S · Class II
- Primescan 2 Multiuse Sleeve — Sirona Dental Systems GmbH · Class II
- COMFORT+ — D.D.S., Inc. · Class II
- PANDA SCANNER — Ziyang Freqty Medical Equipment Co., Ltd. · Class II
- INTELLISCAN 3D® Intraoral Scanner — Shining 3D Tech Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Hdx Will Corp.
Sources (1)
- FDA UDI ec00d389-9ae6-461f-9c03-21464073e029 34 fields · synced May 30, 2026