FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca Emerald S
DI: 00858809006224
·
Model: 15600140 Emerald S Scanner Kit, Cariosity, US
·
D4D TECHNOLOGIES, LLC
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Emerald S
- Primary DI
- 00858809006224
- Version / Model
- 15600140 Emerald S Scanner Kit, Cariosity, US
- Company Name
- D4D TECHNOLOGIES, LLC
- Labeler DUNS
- 138121202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-06
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 1aec8740-4f55-4bef-95f8-1eceb7a3835e
Device Description
Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600141 - Emerald S Scanner Accessories Qty 1 - 15693001 Cariosity Tip
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NTK | Caries Detector, Laser Light, Transmission | Dental | 872.1745 | 2 |
| 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 |
|---|---|---|---|---|
| 33995 | Dental caries detector, optical induced fluorescence | A mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 00858809006170 | GS1 | ||||
| Primary | 00858809006224 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 15 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 28 – 60 Degrees Celsius