Temptation NOW® A2 76g 152452

GUDID 00359883003852

Crown and Bridge Temporary Resin

DEN-MAT HOLDINGS, LLC

Temporary dental crown/bridge resin
Primary Device ID00359883003852
NIH Device Record Key11c7e249-fc5d-4a58-9c50-38d1285f881f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemptation NOW® A2 76g
Version Model Number152452
Catalog Number152452
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
Phone+1(800)433-6628
Emailinfo@denmat.com

Device Dimensions

Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram
Weight76 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 73 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight or the chairlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883003852 [Primary]

FDA Product Code

EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-20
Device Publish Date2025-03-12

Devices Manufactured by DEN-MAT HOLDINGS, LLC

00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack2025-03-26 Gingival Retraction Solution
00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit2025-03-26 Gingival Retraction Solution
00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack2025-03-24 VPS Impression Material
00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack2025-03-21 Wheel, Polishing Agent
00359883006501 - Clinician's Choice® G5 Sample Pack2025-03-21 Dental coating, tooth-desensitizing, professional
00359883000608 - PowerMix™ Automatic Impression Material Dispenser2025-03-20 Two-component dental material applicator, electric
00359883000615 - PowerMix™ Dynamic Mixing Tips2025-03-20 Dental material mixing nozzle, non-sterile
00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange2025-03-20 Device to engage the matrices and separate teeth

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.