FDA UDI
In Commercial Distribution
🇺🇸 United States
NUPRO®
DI: D0038013511
·
Model: 801351
·
Dentsply Professional
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- NUPRO®
- Primary DI
- D0038013511
- Version / Model
- 801351
- Catalog Number
- 801351
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-11-09
- Public Version
- 1
- Public Version Date
- 2022-11-17
- Public Version Status
- New
- Public Device Record Key
- 79002c47-d633-4218-8b45-4ffe11f92edd
Device Description
NUPRO® Shimmer® Polishing Paste for Dental Restorations
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11168 | Dentifrice | A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D0038013510 | HIBCC | ||||
| Primary | D0038013511 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 filled syringe, 4gr each |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Close lid immediately after use to avoid moisture loss.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store above 25 degrees Celsius or 77 degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight.