Cerinate® 033909900

GUDID D8130339099000

SH MOD II SYSTEM BY CERINATE

DEN-MAT HOLDINGS, LLC

Dental composite resin
Primary Device IDD8130339099000
NIH Device Record Key899581ac-ed87-4131-98fa-34421beb1dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameCerinate®
Version Model Number033909900
Catalog Number033909900
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling 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
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8130339099000 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Cerinate®]

D813LUM10050LUMINEERS STARTER KIT
D8130339099500CERI SH MOD II SYS CUSTOM KIT      
D8130339099000SH MOD II SYSTEM BY CERINATE
D8130313811000LUMINEERS PLACEMENT KIT
D813030967101B0TETRAPQ D/C INIT 4g
D8130304025501ETCH'N'SEAL RED 8pc SY KIT

Trademark Results [Cerinate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CERINATE
CERINATE
73523399 1362864 Live/Registered
DEN-MAT, INC.
1985-02-22

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