Harmony PF 582016

GUDID D7075820160

Harmony PF 50 g

IVOCLAR VIVADENT, INC.

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Primary Device IDD7075820160
NIH Device Record Keyaefb4318-cd2f-4368-9f33-ff60c8386bb6
Commercial Distribution Discontinuation2021-06-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHarmony PF
Version Model Number582016
Catalog Number582016
Company DUNS176935203
Company NameIVOCLAR VIVADENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7075820160 [Primary]

FDA Product Code

EJTAlloy, gold-based noble metal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-06-24
Device Publish Date2018-10-29

On-Brand Devices [Harmony PF]

D7075820160Harmony PF 50 g
D7075766000Harmony PF 25 g
D7075765910Harmony PF 100 g
D7075820150Harmony PF 1oz/31 g
D7075820130Harmony PF 5 g

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