SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE
- Primary DI
- D77819960101
- Brand
- SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE
- Company
- SCOTT'S DENTAL SUPPLY L.L.C.
- Model
- 199-6010
- Catalog number
- 199-6010
- Device description
- Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
- Published
- 2017-05-04
- 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
Product Codes
| Code | Name |
|---|
| KLE | Agent, Tooth Bonding, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D77819960101 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 3 | Milliliter |
| Weight | 1 | Gram |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 10 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 137217043
- 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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| D77819950570 | Scott's Select ColorFil Single-Shade Prismatic | 199-5057 | 199-5057 | 2024-08-26 |
| D77819950590 | Scott's Select ColorFil Blocker | 199-5059 | 199-5059 | 2024-08-26 |
| D77835054990 | Scott's Select Nitrile Gloves | 350-5499 | 350-5499 | 2024-08-22 |
| D77835055000 | Scott's Select Nitrile Gloves | 350-5500 | 350-5500 | 2024-08-22 |
| D77835055050 | Scott's Select Nitrile Gloves | 350-5505 | 350-5505 | 2024-08-22 |
| D77835055110 | Scott's Select Nitrile Gloves | 350-5511 | 350-5511 | 2024-08-22 |
| D77835086300 | Scott's Select Latex Gloves | 350-8630 | 350-8630 | 2024-08-22 |
| D77835086320 | Scott's Select Latex Gloves | 350-3632 | 350-3632 | 2024-08-22 |
| D77835086340 | Scott's Select Latex Gloves | 350-8634 | 350-8634 | 2024-08-22 |
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