FDA UDI
In Commercial Distribution
🇺🇸 United States
DentalDB
DI: 04260521361028
·
Model: 3.0 (ChairsideCAD)
·
exocad GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DentalDB
- Primary DI
- 04260521361028
- Version / Model
- 3.0 (ChairsideCAD)
- 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
- 2
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 57b11b02-5ce4-4178-a80d-616c24b24617
- Distribution End Date
- 2026-10-26
Device Description
DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental laboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to and from remote facilities. DentalDB is intended for use by trained professionals, such as dental technicians and dentists.
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 |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60724 | Multidisciplinary medical image management software | A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260521361028 | GS1 |