ORTHOSOURCE
- Primary DI
- D911557607K0
- Brand
- ORTHOSOURCE
- Company
- ORTHOSOURCE
- Model
- 557-607-K
- Device description
- Blue Permaband Composite Light Cure Band Cement 7gm KIT
- Published
- 2019-11-20
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D911557607K0 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 151289394
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D911618002W1000 | ORTHOSOURCE | 618-002W | 2022-11-11 | |
| D9116180040 | ORTHOSOURCE | 618-004 | 2022-11-11 | |
| D911618004W1000 | ORTHOSOURCE | 618-004W | 2022-11-11 | |
| D9116180060 | ORTHOSOURCE | 618-006 | 2022-11-11 | |
| D911618006W1000 | ORTHOSOURCE | 618-006W | 2022-11-11 | |
| D9116180080 | ORTHOSOURCE | 618-008 | 2022-11-11 | |
| D911618008W1000 | ORTHOSOURCE | 618-008W | 2022-11-11 | |
| D9116180140 | ORTHOSOURCE | 618-014 | 2022-11-11 | |
| D911618014W1000 | ORTHOSOURCE | 618-014W | 2022-11-11 | |
| D9116180161000 | ORTHOSOURCE | 618-016 | 2022-11-11 | |
| D911618016W1000 | ORTHOSOURCE | 618-016W | 2022-11-11 | |
| D9116180171000 | ORTHOSOURCE | 618-017 | 2022-11-11 | |
| D911618017W1000 | ORTHOSOURCE | 618-017W | 2022-11-11 | |
| D9116180181000 | ORTHOSOURCE | 618-018 | 2022-11-11 | |
| D911618018W1000 | ORTHOSOURCE | 618-018W | 2022-11-11 | |
| D9116180191000 | ORTHOSOURCE | 618-019 | 2022-11-11 | |
| D911618019W1000 | ORTHOSOURCE | 618-019W | 2022-11-11 | |
| D9116180201000 | ORTHOSOURCE | 618-020 | 2022-11-11 | |
| D911618020W1000 | ORTHOSOURCE | 618-020W | 2022-11-11 | |
| D9116180211000 | ORTHOSOURCE | 618-021 | 2022-11-11 |