FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIOS
DI: 05902729753753
·
Model: TST-11
·
3shape Trios A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TRIOS
- Primary DI
- 05902729753753
- Version / Model
- TST-11
- Company Name
- 3shape Trios A/S
- Labeler DUNS
- 305225025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-26
- Public Version
- 1
- Public Version Date
- 2022-10-04
- Public Version Status
- New
- Public Device Record Key
- 5ff2e5e2-53ca-40fb-9fcc-8fbb25602fa4
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
- Yes
- 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 |
|---|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | Dental | 872.1745 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63669 | Intraoral optical scanning system | An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05902729753760 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 05902729753753 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221249 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 110 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit