Harmony Implant Cement HAR

GUDID D820HAR0

Cement, Dental.

DENALI CORPORATION

Dental composite resin
Primary Device IDD820HAR0
NIH Device Record Key23653b81-3d7f-4fcd-8231-3313b58f105a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony Implant Cement
Version Model NumberEnamel White
Catalog NumberHAR
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
HIBCCD820HAR0 [Primary]

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

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D820ALAYNT3ML0 - AuraLay Pit and Fissure Sealant2018-07-06 Pit and Fissure Sealant, Dental.
D820ALAYOW0 - AuraLay Pit and Fissure Sealant2018-07-06 Pit and Fissure Sealant, Dental.
D820ALAYOW3ML0 - AuraLay Pit and Fissure Sealant2018-07-06 Pit and Fissure Sealant, Dental.
D820ALAYXFNT0 - AuraLay XF Pit and Fissure Sealant2018-07-06 Pit and Fissure Sealant, Dental.

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