Roydent Gutta Percha
- Primary DI
- D809504015R0
- Brand
- Roydent Gutta Percha
- Company
- ROYDENT DENTAL PRODUCTS INC
- Model
- 504015R
- Catalog number
- 504015R
- Device description
- Gutta Percha Points Size Size: 15 .04 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 |
|---|---|---|---|---|
| D809504015R1 | Primary | HIBCC | 0 | |
| D809504015R0 | 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D80906319015R0 | Endodontic Hand Instruments | 06319015R | 06319015R | 2022-11-29 |
| D80906319010R0 | Endodontic Hand Instruments | 06319010R | 06319010R | 2022-11-10 |
| D80906319020R0 | Endodontic Hand Instruments | 06319020R | 06319020R | 2022-11-09 |
| D80906319025R0 | Endodontic Hand Instruments | 06319025R | 06319025R | 2022-11-09 |
| D80906319160R0 | Endodontic Hand Instruments | 06319160R | 06319160R | 2022-11-09 |
| D80906321006R0 | Endodontic Hand Instruments | 06321006R | 06321006R | 2022-11-09 |
| D80906321008R0 | Endodontic Hand Instruments | 06321008R | 06321008R | 2022-11-09 |
| D80906321010R0 | Endodontic Hand Instruments | 06321010R | 06321010R | 2022-11-09 |
| D80906321012R0 | Endodontic Hand Instruments | 06321012R | 06321012R | 2022-11-09 |
| D80906321015R0 | Endodontic Hand Instruments | 06321015R | 06321015R | 2022-11-09 |
| D80906321017R0 | Endodontic Hand Instruments | 06321017R | 06321017R | 2022-11-09 |
| D80906321020R0 | Endodontic Hand Instruments | 06321020R | 06321020R | 2022-11-09 |
| D80906321025R0 | Endodontic Hand Instruments | 06321025R | 06321025R | 2022-11-09 |
| D80906321030R0 | Endodontic Hand Instruments | 06321030R | 06321030R | 2022-11-09 |
| D80906321035R0 | Endodontic Hand Instruments | 06321035R | 06321035R | 2022-11-09 |
| D80906321040R0 | Endodontic Hand Instruments | 06321040R | 06321040R | 2022-11-09 |
| D80906321045R0 | Endodontic Hand Instruments | 06321045R | 06321045R | 2022-11-09 |
| D80906321050R0 | Endodontic Hand Instruments | 06321050R | 06321050R | 2022-11-09 |
| D80906321055R0 | Endodontic Hand Instruments | 06321055R | 06321055R | 2022-11-09 |
| D80906321060R0 | Endodontic Hand Instruments | 06321060R | 06321060R | 2022-11-09 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06978880221102 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221119 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221126 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221133 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221140 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221157 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221164 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221171 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221188 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221195 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221201 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221218 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221225 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221232 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221249 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221256 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221263 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221270 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221287 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221294 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221300 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221317 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221324 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221331 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221348 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221355 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221362 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221379 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221386 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |
| 06978880221393 | Zarc | Shanghai Xing Yu Medical Equipment Co.,Ltd. | EKM | 2026-03-09 |