UltraBond® Clear UB2001

GUDID D813UB20010

ULTRABOND CLR RFL KIT CLR SH

DEN-MAT HOLDINGS, LLC

Dental composite resin
Primary Device IDD813UB20010
NIH Device Record Keycd1a8d4f-a290-4892-b1a9-ec2f3f35d939
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraBond® Clear
Version Model NumberUB2001
Catalog NumberUB2001
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

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75
Handling Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 75 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate for maximum shelf-life
Special Storage Condition, SpecifyBetween 0 and 0 *Recommended temperature when used is 70-75

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813UB20010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [UltraBond® Clear]

D813UB20020ULTRABOND CLR RFL KIT NAT SH
D813UB20010ULTRABOND CLR RFL KIT CLR SH
D813UB20000ULTRABOND CLEAR INTRO KIT

Trademark Results [UltraBond]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRABOND
ULTRABOND
90580642 not registered Live/Pending
ZHEJIANG ALWSCI TECHNOLOGIES CO.,LTD.
2021-03-15
ULTRABOND
ULTRABOND
88316440 not registered Dead/Abandoned
Stellar Industries Corp.
2019-02-26
ULTRABOND
ULTRABOND
87484315 not registered Dead/Abandoned
Fairview Architectural LLC
2017-06-12
ULTRABOND
ULTRABOND
86217456 4679969 Live/Registered
Baker Hughes Incorporated
2014-03-11
ULTRABOND
ULTRABOND
85225288 not registered Dead/Abandoned
Momentive Specialty Chemicals Inc.
2011-01-25
ULTRABOND
ULTRABOND
79336357 not registered Live/Pending
J. & P. Coats, Limited
2022-01-21
ULTRABOND
ULTRABOND
78936611 3546959 Live/Registered
Hernon Manufacturing, Inc.
2006-07-25
ULTRABOND
ULTRABOND
78775766 not registered Dead/Abandoned
Miller, Derek J.
2005-12-18
ULTRABOND
ULTRABOND
78053768 3265593 Live/Registered
MAPEI S.P.A.
2001-03-19
ULTRABOND
ULTRABOND
77380298 3826806 Live/Registered
Mycone Dental Supply Co., Inc.
2008-01-25
ULTRABOND
ULTRABOND
76245228 2647011 Dead/Cancelled
Corn Products International, Inc.
2001-04-23
ULTRABOND
ULTRABOND
76084224 2892199 Dead/Cancelled
ENVIRO-COATINGS CANADA LTD.
2000-07-05
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