Clinician's Choice® G5 Sample Pack 972605

GUDID 00359883006501

Dental coating, tooth-desensitizing, professional

DEN-MAT HOLDINGS, LLC

Dental coating, tooth-desensitizing, professional
Primary Device ID00359883006501
NIH Device Record Key0a6d2a4f-b470-4358-b7d6-ad715b84090d
Commercial Distribution StatusIn Commercial Distribution
Brand NameClinician's Choice® G5 Sample Pack
Version Model Number972605
Catalog Number972605
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com
Phone+1(800)433-6628
Emailinfo@denmat.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *G5 has a three year shelf life when kept below 77°F/25°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat; Store in original tightly closed container; Store in a well-ventilated place; Storage Environment Temperature: less than 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883006501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-21
Device Publish Date2025-03-13