Evanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack 973208

GUDID 07540172019354

Dental Composite Resin

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID07540172019354
NIH Device Record Key664a7878-fcae-4caa-badd-5901b237e045
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvanesce™ Nano-Enhanced Universal Restorative Single Dose Sample Pack
Version Model Number973208
Catalog Number973208
Company DUNS626406016
Company NameCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com
Phone+1(800)265-3444
Emailinfo@clinicianschoice.com

Device Dimensions

Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram
Device Size Text, specify0
Weight0.25 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Protect from direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS107540172019354 [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 Date2023-02-10
Device Publish Date2023-02-02