MPa™ Max Adhesive with Chlorhexidine 266506

GUDID 00359883004439

Dental Bonding Agent

DEN-MAT HOLDINGS, LLC

Dentine bonding agent/set
Primary Device ID00359883004439
NIH Device Record Keyda3f52ac-173a-427a-a5fb-76c387ef0b9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPa™ Max Adhesive with Chlorhexidine
Version Model Number266506
Catalog Number266506
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

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
Total Volume5 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat, sparks and flame. Refrigerate if not used on a daily basis
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883004439 [Primary]

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 Date2025-03-20
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.