FDA UDI
In Commercial Distribution
🇺🇸 United States
All-Ceramic Crown
DI: 06975031820252
·
Model: /
·
Beijing Yingguan Dental Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- All-Ceramic Crown
- Primary DI
- 06975031820252
- Version / Model
- /
- Company Name
- Beijing Yingguan Dental Technology Co., Ltd.
- Labeler DUNS
- 560456141
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 1
- Public Version Date
- 2022-10-10
- Public Version Status
- New
- Public Device Record Key
- 298074b0-50ea-4847-b1ee-d17706acbc36
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ultraviolet Light", "Ozone"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NSP | Restoration, Porcelain | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38594 | Custom-made dental crown, ceramic | A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975031820252 | GS1 |