Identity
- Trade Name
- Scott's Select ColorFil Single-Shade Prismatic FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light cured one-for-most shades dental restorative packaged in 20 unit dose compules. Features & Benefits: Light cure restorative matches most shades, spherical nano-filler, pigment-free, light diffraction technology, radiopaque, excellent handling, sculptable consistency, polishes to high gloss, opalescent very low shrinkage, has companion blocker for masking dark stains and discolorations. For more information visit: https://www.scottsdental.com/colorfil-single-shade.html?queryID=1154e294ba00ec9ec0e218210e79866d&objectID=49216&indexName=magento2_production_default_products FDA UDI
- Model / Reference
- 199-5057 FDA UDI
- Description
- Light cured one-for-most shades dental restorative packaged in 20 unit dose compules. Features & Benefits: Light cure restorative matches most shades, spherical nano-filler, pigment-free, light diffraction technology, radiopaque, excellent handling, sculptable consistency, polishes to high gloss, opalescent very low shrinkage, has companion blocker for masking dark stains and discolorations. For more information visit: https://www.scottsdental.com/colorfil-single-shade.html?queryID=1154e294ba00ec9ec0e218210e79866d&objectID=49216&indexName=magento2_production_default_products FDA UDI
Identifiers
- Catalog Number
- 199-5057 FDA UDI
- Primary DI / UDI-DI
- D77819950571 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — .25 Gram FDA UDI
Category: Dental composite resin
Scott's Select ColorFil Single-Shade Prismatic by Scott's Dental Supply L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI ac0f5f55-a7db-436b-9a19-50e5b229f36c 37 fields · synced Jun 8, 2026