Roydent Gutta Percha
- Primary DI
- D809506015R0
- Brand
- Roydent Gutta Percha
- Company
- ROYDENT DENTAL PRODUCTS INC
- Model
- 506015R
- Catalog number
- 506015R
- Device description
- Gutta Percha Points Size Size: 15 .06 Taper
- Published
- 2022-10-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EKM | GUTTA-PERCHA |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKM | Gutta-Percha | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D809506015R1 | Primary | HIBCC | 0 | |
| D809506015R0 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
| Liquid Chemical |
Regulatory Flags
- DUNS number
- 131487225
- Device count
- 120
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- true
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| D80906321040R0 | Endodontic Hand Instruments | 06321040R | 06321040R | 2022-11-09 |
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