FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 10850002458654
·
Model: 502601-28
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 10850002458654
- Version / Model
- 502601-28
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-02-10
- Public Version
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- fba9e768-4d63-4a2d-84c9-97d8f92fe704
Device Description
Advance Calcium Hydroxide Value Pack, 20-1.2ml syringes
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KIF | RESIN, ROOT CANAL FILLING | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60275 | Endodontic temporary cement | A viscous material intended for the temporary obturation of a prepared root canal, to maintain relative sterility between procedures and facilitate healing. Commonly referred to as temporary filling or sealer, it is typically a zinc or calcium cement-based paste that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a prefilled tube or syringe; some types require the use of a separate sealer. 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 | 00850002458657 | GS1 | ||||
| Primary | 10850002458654 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963922 | 000 |