Infinity® 039620150

GUDID D8130396201500

INFINITY ORIGINAL A & B KIT

DEN-MAT HOLDINGS, LLC

Dental composite resin
Primary Device IDD8130396201500
NIH Device Record Keya0dbea18-9e48-4231-bda8-67adb75687d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinity®
Version Model Number039620150
Catalog Number039620150
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
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
Phone1-800-433-6628
Emailinfo@denmat.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 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 Infinity for maximum shelf-life
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130396201500 [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 [Infinity®]

D81380000SOLVENEX 8oz
D8130396901100INFINITY SY INTRO KIT
D8130396812000INFINITY SE SY VALUE KIT
D8130396802000INFINITY SE SY KIT
D8130396801000INFINITY SY VALUE KIT
D8130396701000INFINITY SY KIT
D8130396201500INFINITY ORIGINAL A & B KIT
D8130396810300INFNTY DCHMB SY SMP BG 1FLW IT

Trademark Results [Infinity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFINITY
INFINITY
98884612 not registered Live/Pending
Tennant Devices and Accessories, LLC
2024-12-04
INFINITY
INFINITY
98761246 not registered Live/Pending
Zevex, Inc.
2024-09-20
INFINITY
INFINITY
98737979 not registered Live/Pending
Marten Group, Inc.
2024-09-06
INFINITY
INFINITY
98643936 not registered Live/Pending
Project Management Institute, Inc.
2024-07-11
INFINITY
INFINITY
98470220 not registered Live/Pending
IBF IP, LLC
2024-03-27
INFINITY
INFINITY
98466286 not registered Live/Pending
IBF IP, LLC
2024-03-25
INFINITY
INFINITY
98454204 not registered Live/Pending
Tanks By Mail Inc
2024-03-18
INFINITY
INFINITY
98433629 not registered Live/Pending
Infinity Generation Inc.
2024-03-05
INFINITY
INFINITY
98338571 not registered Live/Pending
Careismatic Brands, LLC
2024-01-02
INFINITY
INFINITY
98293120 not registered Live/Pending
PREFERRED COLLECTIONS INC.
2023-11-30
INFINITY
INFINITY
98275942 not registered Live/Pending
Capital One Financial Corporation
2023-11-17
INFINITY
INFINITY
98242984 not registered Live/Pending
IGH Holding Inc.
2023-10-27
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