Instrument Set
- Primary DI
- D9498000212
- Brand
- Instrument Set
- Company
- Bioclear Matrix Systems
- Model
- Basic
- Device description
- Convenience kit of Bioclear products used in dental restorations.
- Published
- 2023-08-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D9498000212 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Manual non-rotary dental instrument handle | A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 059020838
- Device count
- 1
- Premarket exempt
- true
- Kit
- true
- Sterilization required before use
- true
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 | |
| D949112011021 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011041 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011081 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011101 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011161 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011500BG1 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112011503 | Bioclear Diamond Wedge | Small | 2023-09-11 | |
| D94911201150BG1 | Bioclear Diamond Wedge | Small | 2023-09-16 | |
| D949112021021 | Bioclear Diamond Wedge | Medium | 2023-09-16 | |
| D949112021041 | Bioclear Diamond Wedge | Medium | 2023-09-16 | |
| D949112021081 | Bioclear Diamond Wedge | Medium | 2023-09-16 | |
| D949112021101 | Bioclear Diamond Wedge | Medium | 2023-09-16 |