FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 10850455007218
·
Model: 1000121
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 10850455007218
- Version / Model
- 1000121
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-06
- Public Version
- 1
- Public Version Date
- 2023-03-14
- Public Version Status
- New
- Public Device Record Key
- bd367bf8-f417-409d-98a6-4c003dba2a1e
Device Description
Advance Temporary Crown & Bridge Material A1 Cartridge + Tips
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 45236 | Temporary dental crown/bridge resin | A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850455007218 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130672 | 000 |