FDA UDI
In Commercial Distribution
🇺🇸 United States
Scott's Select ColorFil Blocker
DI: D77819950530
·
Model: 199-5053
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Scott's Select ColorFil Blocker
- Primary DI
- D77819950530
- Version / Model
- 199-5053
- Catalog Number
- 199-5053
- 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
- 2024-08-26
- Public Version
- 1
- Public Version Date
- 2024-09-03
- Public Version Status
- New
- Public Device Record Key
- fd976d47-aeb9-47be-a075-1578c41ac94a
Device Description
ColorFil Blocker masks stains and discolorations for optimal esthetics when used in conjunction with ColorFil Single-Shade Prismatic. Packaged in a 3.5g syringe. For more information visit: https://www.scottsdental.com/colorfil-single-shade.html?queryID=1154e294ba00ec9ec0e218210e79866d&objectID=49216&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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | D77819950530 | HIBCC |
Customer Contacts
- Phone
- (800) 901-3368
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 3.5 | 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