Complete Bonding Kit
- Primary DI
- D7796540053
- Brand
- Complete Bonding Kit
- Company
- COSMEDENT, INC.
- Model
- 654005
- Catalog number
- 654005
- Device description
- Complete Bonding Kit includes 1 bottle of Primer/Unfilled Resin, 1 bottle of Dual-Cure Catalyst, 1 bottle of Unfilled Resin, one #1 brush/straight; and one #1 brush/bent in 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 |
|---|
| D7796540053 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental composite adhesive kit | A collection of devices intended to be used to bond attachments such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment. The adhesives are typically based on light-cured bonding composites (e.g., 400-500nm range). The contents of this kit may include etchant, bonding resin, bonding paste, spatula, brushes, and a paper pad. This is a reusable 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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