Prepi Burs
- Primary DI
- D716PI00560
- Brand
- Prepi Burs
- Company
- TULSA DENTAL PRODUCTS LLC
- Model
- PI0056
- Catalog number
- PI0056
- Device description
- Prepi: 6pk .50mm SS PREPI BUR
- Published
- 2022-10-17
- 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
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EJL | BUR, DENTAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EJL | Bur, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D716PI00561 | Primary | HIBCC | 0 | |
| D716PI00560 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Carbide dental bur, reusable | A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 942778564
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D716PUENDO11 | ProUltra | PUENDO1 | PUENDO1 | 2016-10-07 |
| D716PUENDO151 | ProUltra | PUENDO1-5 | PUENDO1-5 | 2016-11-11 |
| D716PUENDO21 | ProUltra | PUENDO2 | PUENDO2 | 2016-10-07 |
| D716PUENDO31 | ProUltra | PUENDO3 | PUENDO3 | 2016-10-07 |
| D716PUENDO41 | ProUltra | PUENDO4 | PUENDO4 | 2016-10-07 |
| D716PUENDO51 | ProUltra | PUENDO5 | PUENDO5 | 2016-10-07 |
| D716PUENDO61 | ProUltra | PUENDO6 | PUENDO6 | 2016-10-07 |
| D716PUENDO681 | ProUltra | PUENDO6-8 | PUENDO6-8 | 2016-11-11 |
| D716PUENDO71 | ProUltra | PUENDO7 | PUENDO7 | 2016-10-07 |
| D716PUENDO81 | ProUltra | PUENDO8 | PUENDO8 | 2016-10-07 |
| D716PUSINE11 | ProUltra | PUSINE1 | PUSINE1 | 2016-10-07 |
| D716PUSINE161 | ProUltra SINE | PUSINE1-6 | PUSINE1-6 | 2016-11-11 |
| D716PUSINE21 | ProUltra | PUSINE2 | PUSINE2 | 2016-10-07 |
| D716PUSINE31 | ProUltra SINE | PUSINE3 | PUSINE3 | 2016-10-07 |
| D716PUSINE41 | ProUltra SINE | PUSINE4 | PUSINE4 | 2016-10-07 |
| D716PUSINE51 | ProUltra SINE | PUSINE5 | PUSINE5 | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE | PUSINE6 | PUSINE6 | 2016-10-07 |
| D716PUSURG11 | ProUltra | PUSURG1 | PUSURG1 | 2016-10-07 |
| D716PUSURG161 | ProUltra | PUSURG1-6 | PUSURG1-6 | 2016-11-11 |
| D716PUSURG21 | ProUltra | PUSURG2 | PUSURG2 | 2016-10-07 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00810126508270 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508294 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508300 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508317 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
| 00810126508324 | Sabur by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | EJL | 2026-03-11 |
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