AuraVeneer Cement AVOW

GUDID D820AVOW1

Cement, Dental.

DENALI CORPORATION

Dental composite resin
Primary Device IDD820AVOW1
NIH Device Record Key8eb43d30-99fc-4365-b1b1-f12d1538213a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuraVeneer Cement
Version Model NumberOff White
Catalog NumberAVOW
Company DUNS191036107
Company NameDENALI CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-781-826-9190
Emaildenalicorp@denalicorporation.com
Phone+1-781-826-9190
Emaildenalicorp@denalicorporation.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD820AVOW [Primary]
HIBCCD820AVOW1 [Package]
Contains: D820AVOW
Package: [4 Units]
In Commercial Distribution

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-04

On-Brand Devices [AuraVeneer Cement]

D820AVOW1Cement, Dental.
D820AVOPW0Aura Veneer Cement - 1.2 mL Single Syringe Opaque White
D820AVC0Cement, Dental.
D820AV3C1OW0Cement, Dental.
D820AV2C2OW0Dental, Cement.
D820AV1OW3OPW0AuraVeneer Cement. Kit of 4 x 1.2 ml Syringes. Shades: 1 Off White - 3 Opaque White
D820AV1C3OW0Cement, Dental.

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