Scott's Select Plus SE Bond Unit Dose
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Basic Information
- Brand Name
- Scott's Select Plus SE Bond Unit Dose
- Primary DI
- D77819910571
- Version / Model
- 199-1057
- Catalog Number
- 199-1057
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-20
- Public Version
- 6
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 565171ea-fb62-41cc-a545-7476098d1ce4
Device Description
SELF-ETCH (SE) BONDING AGENT is indicated for the bonding of direct composite, resin modified glass ionomers or compomers to dentin/enamel. SE BONDING AGENT is a self-etch, light-cure one component adhesive resin system designed to bond composites to enamel and dentin. It is a quick and easy way to bond composites to the tooth. SE BONDING AGENT provides "all in one": etching of, priming of and adhesion to enamel and dentin. This system is responsive to any dental curing light; the curing times can vary with the radiance of the light source. SE Bonding Agent is a dimethacrylate based bonding system with photosensitizers. This kit contains 50 unit dose tips and 50 applicator brushes. Instructions for use and SDS available at https://www.scottsdental.com/select-plus-bond.html
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D77819910571 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | .125 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius