FDA UDI
In Commercial Distribution
🇺🇸 United States
Edge One R GP
DI: 08800069209206
·
Model: EORGP35-1
·
SURE DENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
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Basic Information
- Brand Name
- Edge One R GP
- Primary DI
- 08800069209206
- Version / Model
- EORGP35-1
- Company Name
- SURE DENT CORPORATION
- Labeler DUNS
- 688273010
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 2
- Public Version Date
- 2025-02-25
- Public Version Status
- Update
- Public Device Record Key
- b64e4651-8f74-4da8-a0cb-55327eaa0e7c
Device Description
Edge One R Gutta Percha Points R35
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 45081 | Synthetic gutta-percha | A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. 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 | 88800069209202 | GS1 | ||||
| Primary | 08800069209206 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature away from direct sunlight