Scott's Select ColorFil Single-Shade Prismatic 199-5057

GUDID D77819950570

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

SCOTT'S DENTAL SUPPLY L.L.C.

Dental composite resin
Primary Device IDD77819950570
NIH Device Record Keyac0f5f55-a7db-436b-9a19-50e5b229f36c
Commercial Distribution StatusIn Commercial Distribution
Brand NameScott's Select ColorFil Single-Shade Prismatic
Version Model Number199-5057
Catalog Number199-5057
Company DUNS137217043
Company NameSCOTT'S DENTAL SUPPLY L.L.C.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com
Phone(800) 901-3368
Emailinfo@scottsdental.com

Device Dimensions

Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram
Weight0.25 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunligt
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD77819950570 [Unit of Use]
HIBCCD77819950571 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26