Geristore® 030451110

GUDID D8130304511100

BIO-CAP KIT

DEN-MAT HOLDINGS, LLC

Dental composite resin
Primary Device IDD8130304511100
NIH Device Record Key54cbfb45-5cec-4aa6-8f4c-793c41a57e2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeristore®
Version Model Number030451110
Catalog Number030451110
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

Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 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
Storage Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 47 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130304511100 [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 [Geristore®]

D81345060GERISTORE A S/S 10g
D813034526101B0GERISTORE PST B SH A3.5 10g
D8130345241010GERISTORE PST B SH A3 10g
D8130345231010GERISTORE PST B SH A2 10g
D8130345221010GERISTORE PST B SH A1 10g
D8130314793000HOLISTORE A AND B JARS
D8130314771000GERISTORE VALUE CUSTOM KIT    
D8130314761100GERISTORE A2 SY INTRO KIT
D8130314585500GERISTORE VALUE SY KIT A2
D8130314577300GERISTORE SY KIT A3.5
D8130314577200GERISTORE SY KIT A3
D8130314575200GERISTORE VALUE SY KIT A3
D8130314575000GERISTORE SY KIT A2
D8130304511100BIO-CAP KIT
D813030450911B0GERISTORE A S/S 10g
D8130398457300GERISTOR SY SMP A2 BAG 1FLW IT

Trademark Results [Geristore]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GERISTORE
GERISTORE
74194248 1706205 Live/Registered
DEN-MAT HOLDINGS, LLC
1991-08-13

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