SofScale™
- Primary DI
- D003A900601
- Brand
- SofScale™
- Company
- Dentsply Professional
- Model
- A90060
- Device description
- SofScale™ Calculus Scaling Gel, Contents: 5 Syringes Scaling Gel (2mL) and 5 Disposable Application Tips
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| ELC | Scaler, ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D003A900602 | Package | HIBCC | 12 | In Commercial Distribution |
| D003A900601 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental scaling solution | A liquid substance used in dentistry to soften and partially solubilize a dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose. It will typically contain acid as a solvent (e.g., hydrochloric) and include other elements (e.g., iodine and excipients). After application, this device cannot be reused. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Total Volume | 2 | Milliliter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not store at temperatures exceeding 25°C |
| Storage Environment Temperature | 5 Degrees Celsius | 25 Degrees Celsius |
Contacts#
| Phone | |
|---|---|
| +1(800)989-8825 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 144140845
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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