FDA UDI
In Commercial Distribution
🇺🇸 United States
BRILLIANT Crios
DI: J00660019992
·
Model: 60019992
·
Coltène/Whaledent AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BRILLIANT Crios
- Primary DI
- J00660019992
- Version / Model
- 60019992
- Catalog Number
- 60019992
- Company Name
- Coltène/Whaledent AG
- Labeler DUNS
- 480017482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-01
- Public Version
- 1
- Public Version Date
- 2018-11-01
- Public Version Status
- New
- Public Device Record Key
- ac057db8-e94a-416b-9232-a26b888d26f5
Device Description
BRILLIANT Crios CEREC/inLab – 5 blocs Size 14, Low Translucent, B3 BRILLIANT Crios is a reinforced composite bloc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM milling process. BRILLIANT Crios is available in a variety of shades and sizes. Composition: Dental glass, cross-linked methacrylates, amorphous silica.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38649 | Resin dental inlay | A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00660019992 | HIBCC |
Customer Contacts
- Phone
- +41717575300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181500 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose to direct sunlight or other heat sources.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage: 4-23 °C / 39-73°F