Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose 323577

GUDID 07540172019712

Dental Composite Resin

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Dental composite resin
Primary Device ID07540172019712
NIH Device Record Keyaee05f63-a491-4aec-9f6a-1be0ff8ead71
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose
Version Model Number323577
Catalog Number323577
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 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 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
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

Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram
Weight0.3 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct sunlight; Storage Environment Temperature: less than 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107540172019712 [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 Date2024-09-25
Device Publish Date2024-09-17