Diamond Wedge
- Primary DI
- D9491120910
- Brand
- Diamond Wedge
- Company
- Bioclear Matrix Systems
- Model
- Long Extra Large
- Device description
- Wedge used in dental restorations.
- Published
- 2023-08-15
- 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
Product Codes
| Code | Name |
|---|
| EJB | Handle, Instrument, Dental |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJB | Handle, Instrument, Dental | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D949112091161 | Primary | HIBCC | 0 | |
| D949112091501 | Primary | HIBCC | 0 | |
| D9491120910 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental wedge, single-use | A dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device. |
Regulatory Flags
- DUNS number
- 059020838
- Device count
- 50
- 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
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D9498010162 | Black Triangle (BT) Kit | Student/EM | | 2024-12-03 |
| D9498271712 | Evolve All-in-One Select Kit | Full | | 2024-12-03 |
| D9498271612 | Evolve All-in-One Select Kit | Student/EM | | 2024-10-22 |
| D9499000412 | BT, Evolve, & DW | Samples for 3M Heaters | | 2024-08-20 |
| D9498270912 | Evolve Matrix Procedure Kit | Brazil | | 2024-07-10 |
| D9495000821 | Bioclear Instrument | TwinRing Forceps | | 2024-04-05 |
| D9498271312 | Select Bioclear Evolve Posterior Kit | Select | | 2024-04-05 |
| D9498271412 | Bioclear Evolve Posterior Kit | Select Add-On Kit | | 2024-04-05 |
| D949208011R1 | Bioclear TwinRing | Molar | | 2023-09-16 |
| D949208021R1 | Bioclear TwinRing | Premolar | | 2023-09-16 |
| D9492080311 | Bioclear TwinRing Molar/Premolar Pack | Molar/Premolar Pack | | 2023-09-16 |
| D949208031K1 | Bioclear TwinRing Molar/Premolar Pack | Molar/Premolar Pack | | 2023-09-16 |
| D949303011B0 | Original Posterior Matrix B Series | B301 Blue | | 2023-09-11 |
| D949303011C0 | Original Posterior Matrix B Series | B301 Clear | | 2023-09-11 |
| D949303021B0 | Original Posterior Matrix B Series | B302 Blue | | 2023-09-11 |
| D949303021C0 | Original Posterior Matrix B Series | B302 Clear | | 2023-09-11 |
| D949303031B0 | Original Posterior Matrix B Series | B303 Blue | | 2023-09-11 |
| D949303031C0 | Original Posterior Matrix B Series | B303 Clear | | 2023-09-11 |
| D949304011B0 | Original Posterior Matrix M Series | M401 Blue | | 2023-09-11 |
| D949304011C0 | Original Posterior Matrix M Series | M401 Clear | | 2023-09-11 |
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