FDA UDI
In Commercial Distribution
🇺🇸 United States
Luminesse Shaded PMMA Discs
DI: D7915301BL10
·
Model: 5301-BL1
·
TALLADIUM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Luminesse Shaded PMMA Discs
- Primary DI
- D7915301BL10
- Version / Model
- 5301-BL1
- Catalog Number
- 5301-BL1
- Company Name
- TALLADIUM, INC.
- Labeler DUNS
- 094430642
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-25
- Public Version
- 1
- Public Version Date
- 2018-12-26
- Public Version Status
- New
- Public Device Record Key
- 5b07d918-f952-4fba-918b-b803589f9732
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34811 | Polymer-based dental model material | A variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7915301BL10 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142371 | 000 |