Prevue Refill Kit
- Primary DI
- D7796040153
- Brand
- Prevue Refill Kit
- Company
- COSMEDENT, INC.
- Model
- 604015
- Catalog number
- 604015
- Device description
- Prevue Try-In Refill Kit includes 5 (2.5g) syringes of Prevue Try-In Gel, 2 Cosmedent brushes (#1 and #3),and Syringe Tips (20 pack-19 gauge).
- Published
- 2016-09-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D7796040153 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental abrasive powder | A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device. |
Regulatory Flags
- DUNS number
- 113911689
- 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
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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