FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 00371347006292
·
Model: ACGP4006
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 00371347006292
- Version / Model
- ACGP4006
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- d7bda243-275c-4156-af08-920f03028092
Device Description
Advance Cobalt Twirl Gutta Percha 40/.06
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
- 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 |
|---|---|---|---|---|
| EKM | GUTTA-PERCHA | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34791 | Root canal obturating point | A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10371347006299 | GS1 | ||||
| Primary | 00371347006292 | GS1 |