Scott's Select ColorFil Flow Single-Shade Prismatic
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Basic Information
- Brand Name
- Scott's Select ColorFil Flow Single-Shade Prismatic
- Primary DI
- D77819950611
- Version / Model
- 199-5061
- Catalog Number
- 199-5061
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-08-27
- Public Version
- 1
- Public Version Date
- 2024-09-04
- Public Version Status
- New
- Public Device Record Key
- 4be2a29d-e972-4114-9c2f-67fbfc797c84
Device Description
ColorFil Flow is a light cure flowable radiopaque composite that color matches to natural tooth shades. This spherical, nano filler composite is ideal for small class I and II restorations, enamel defects and extended fissure sealing. ColorFil Flow features high radiopacity and toothlike opalescence with excellent physical properties and handling. Indicated for: Small class I and II restorations, Small enamel defects, Extended fissure sealings. For more information visit: https://www.scottsdental.com/colorfil-flow-single-shade.html?queryID=44778907d73cbed73829f71103572f05&objectID=49219&indexName=magento2_production_default_products
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 872.3765 | 2 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D77819950610 | HIBCC | ||||
| Primary | D77819950611 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius