XL 582194

GUDID D7075821940

X-L 1oz/31 g

IVOCLAR VIVADENT, INC.

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Primary Device IDD7075821940
NIH Device Record Keyb35825b1-4662-4297-95df-0327557c7019
Commercial Distribution StatusIn Commercial Distribution
Brand NameXL
Version Model Number582194
Catalog Number582194
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
HIBCCD7075821940 [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 [XL]

D7075821950X-L 100 g
D7075821940X-L 1oz/31 g
D7075821930X-L 25 g
D7075821910X-L 5 g

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