FDA UDI
In Commercial Distribution
🇺🇸 United States
ChairsideCAD
DI: 04260521363022
·
Model: 3.0 Galway
·
exocad GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ChairsideCAD
- Primary DI
- 04260521363022
- Version / Model
- 3.0 Galway
- Company Name
- exocad GmbH
- Labeler DUNS
- 341575872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-26
- Public Version
- 3
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- a1ba16b2-a215-4415-b10a-2d5d4a96714e
- Distribution End Date
- 2026-10-26
Device Description
ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Dental | 872.3661 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38597 | Dental milling system, CAD/CAM, chairside | An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260521363022 | GS1 |