ResinBlend LV Composite Blending Resin 151201

GUDID 00359883003791

Dental unfilled resin sealant/coating

DEN-MAT HOLDINGS, LLC

Dental unfilled resin sealant/coating
Primary Device ID00359883003791
NIH Device Record Keyeaf116e7-a12c-40da-92f2-8fce6fbdcfca
Commercial Distribution StatusIn Commercial Distribution
Brand NameResinBlend LV Composite Blending Resin
Version Model Number151201
Catalog Number151201
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 Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
Storage Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.

Device Identifiers

Device Issuing AgencyDevice ID
GS100359883003791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-03-20
Device Publish Date2025-03-12

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