FDA UDI
In Commercial Distribution
🇺🇸 United States
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar
DI: 00810118102424
·
Model: DUL7407L
·
NUSMILE, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NuSmile BioFlx Posterior Replacement Crown - First Primary Molar
- Primary DI
- 00810118102424
- Version / Model
- DUL7407L
- Company Name
- NUSMILE, LTD.
- Labeler DUNS
- 185497372
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-20
- Public Version
- 1
- Public Version Date
- 2023-02-28
- Public Version Status
- New
- Public Device Record Key
- 87eaa409-d156-45a2-b1d1-29a3f48ea401
Device Description
NuSmile BioFlx Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 7 / Light Shade
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ELZ | Crown, Preformed | Dental | 872.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34976 | Preformed dental crown, temporary | A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810118102424 | GS1 |
Customer Contacts
- Phone
- 7138610033
- [email protected]