Porcelain Repair Kit (Clear)
- Primary DI
- D7796610153
- Brand
- Porcelain Repair Kit (Clear)
- Company
- COSMEDENT, INC.
- Model
- 661015
- Catalog number
- 661015
- Device description
- Porcelain Repair Kit (Clear) includes 1 (2.5 cc) PorcelETCH™ Clear, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
- 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 |
|---|
| D7796610153 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental repair kit, ceramic | A packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. 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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