Identity
- Trade Name
- Gro3X DIU FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software. FDA UDI
- Model / Reference
- DIU-3D-71-001 FDA UDI
- Description
- Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006572501 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
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
Yes
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: Dental milling system, CAD/CAM, chairside
Gro3X DIU by Gro3x, 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
- Itero Element — Align Technology, Inc. · 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
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
- Gro3x, Inc.
Sources (1)
- FDA UDI e1da7423-4f88-456d-89fe-dd2cbc4de59c 34 fields · synced Jun 8, 2026