Affinity™ Tray Adhesive 034300

GUDID 07540172016797

Adherant for impression materials and plastic trays

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Dental impression adhesive
Primary Device ID07540172016797
NIH Device Record Keyc04ee981-866b-4ec6-a91d-dd491defaad0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffinity™ Tray Adhesive
Version Model Number034300
Catalog Number034300
Company DUNS626406016
Company NameCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 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
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

Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter
Device Size Text, specify0
Total Volume30 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sources of ignition. Protected from light. Store in well ventilated place.

Device Identifiers

Device Issuing AgencyDevice ID
GS107540172016797 [Primary]
GS107540172019255 [Direct Marking]

FDA Product Code

KOOADHESIVE, DENTURE, POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIUM DOUBLE SALT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12