FDA UDI
In Commercial Distribution
🇺🇸 United States
BRILLIANT COMPONEER
DI: J00660023191
·
Model: 60023191
·
Coltène/Whaledent AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BRILLIANT COMPONEER
- Primary DI
- J00660023191
- Version / Model
- 60023191
- Catalog Number
- 60023191
- Company Name
- Coltène/Whaledent AG
- Labeler DUNS
- 480017482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-30
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- e9106aed-b850-4519-8b83-cd80a37976fa
Device Description
BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite enamel shells for direct veneering. BRILLIANT COMPONEER lower jaw M translucent 41.
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 |
|---|---|---|---|---|
| 38645 | Dental veneer, professional | A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00660023191 | HIBCC |
Customer Contacts
- Phone
- +41717575300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191385 | 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
- Store at 4-23 °C / 39-73 °F