UltraBond® Clear UB2002

GUDID D813UB20020

ULTRABOND CLR RFL KIT NAT SH

DEN-MAT HOLDINGS, LLC

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

Primary Device ID	D813UB20020
NIH Device Record Key	583acb2b-1d9c-4d42-8b83-b572b34a4f7e
Commercial Distribution Status	In Commercial Distribution
Brand Name	UltraBond® Clear
Version Model Number	UB2002
Catalog Number	UB2002
Company DUNS	809857704
Company Name	DEN-MAT HOLDINGS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com
Phone	1-800-433-6628
Email	info@denmat.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813UB20020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K881918

FDA Product Code

EMA	Cement, Dental

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

On-Brand Devices [UltraBond® Clear]

D813UB20020	ULTRABOND CLR RFL KIT NAT SH
D813UB20010	ULTRABOND CLR RFL KIT CLR SH
D813UB20000	ULTRABOND CLEAR INTRO KIT

Trademark Results [UltraBond]

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