Harmony Hard 582075

GUDID D7075820750

Harmony Hard 1oz/31 g

IVOCLAR VIVADENT, INC.

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Primary Device IDD7075820750
NIH Device Record Keyc5476916-8e17-41f6-8fd5-8bb8ebb0ee31
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony Hard
Version Model Number582075
Catalog Number582075
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 Datetrue
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
HIBCCD7075820750 [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 Date2022-04-27
Device Publish Date2018-10-29

On-Brand Devices [Harmony Hard]

D7075820760Harmony Hard 100 g
D7075820750Harmony Hard 1oz/31 g
D7075820740Harmony Hard 25 g
D7075820720Harmony Hard 5 g

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