Profiling Bur for ISI/TSI/ERI
- Primary DI
- D7850100PB0
- Brand
- Profiling Bur for ISI/TSI/ERI
- Company
- OCO BIOMEDICAL INC
- Model
- 5mm Profiling Bur
- Catalog number
- 0100
- Device description
- 5mm Profiling Bur 5mm Diameter
- Published
- 2016-04-28
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| DZN | Instruments, Dental Hand |
| EJL | Bur, Dental |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DZN | Instruments, Dental Hand | Dental | 1 |
| EJL | Bur, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D7850100PB0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Steel dental bur | A rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. 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
- 094146123
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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 |
|---|
| D785OTCAP100 | 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | OT CAP 10 | OT CAP 10 | 2026-02-04 |
| D785OTCAP40 | 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT | OT CAP 4 | OT CAP 4 | 2026-02-04 |
| D785OTPINK40 | 4 PACK OT EQUATOR PINK INSERTS | OT PINK 4 | OT PINK 4 | 2026-02-04 |
| D785OTPU20 | 2 PACK OT EQUATOR IMPRESSION COPING | OT PU 2 | OT PU 2 | 2026-02-04 |
| D785OTYELLOW40 | 4 PACK OT EQUATOR YELLOW INSERT | OT YELLOW 4 | OT YELLOW 4 | 2026-02-04 |
| D78589490 | TSI/ERI Locator Abutment | Locator Abutment 0mm | 8949 | 2025-09-03 |
| D7850330T0 | Osteotomy Former | 3.3mm Osteotomy Former | 0330TN | 2024-12-03 |
| D7853610ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3610 ENGAGE | 2024-12-03 |
| D7853610ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3610 Engage Plus | 2024-12-03 |
| D7853612ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3612 ENGAGE | 2024-12-03 |
| D7853612ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3612 Engage plus | 2024-12-03 |
| D7853614ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3614 ENGAGE | 2024-12-03 |
| D7853614ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3614 Engage Plus | 2024-12-03 |
| D7853616ENGAGE0 | Two Stage Bone Level Dental Implant | Engage | 3616 ENGAGE | 2024-12-03 |
| D7853616ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 3616 Engage Plus | 2024-12-03 |
| D785SURGICALGUIDE0 | SURGICAL GUIDE | 3D PRINTED SURGICAL GUIDE | SURGICAL GUIDE | 2024-12-03 |
| D7856006ENGPLS0 | Two Stage Bone Level Implant | Engage Plus | 6006 Engage Plus | 2024-09-27 |
| D785293325CBTI0 | SDI Crown and Bridge Abutments (Ti) | 2.9/3/3.25MM SDI C&B ABUTMENT | 2.9/3/3.25 CB (Ti) | 2024-06-28 |
| D785SDI2225CBTI0 | SDI Crown and Bridge Abutments (Ti) | 2.2/2.5MM SDI C&B ABUTMENT | SDI 2.2/2.5 CB (Ti) | 2024-06-28 |
| D785002CAPWOBN0 | HOUSING CAP WITH O-RING | 002 CAP W/O-RING (002BN900) | 002 CAP W/O-RING (002BN900) | 2024-06-26 |
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