XLX 583321

GUDID D7075833210

XL-X Plus 25 g

IVOCLAR VIVADENT, INC.

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Primary Device IDD7075833210
NIH Device Record Key78428ead-5d7a-4f36-992d-5fd2365ea926
Commercial Distribution Discontinuation2021-03-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameXLX
Version Model Number583321
Catalog Number583321
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
HIBCCD7075833210 [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 Date2021-03-04
Device Publish Date2018-10-29

On-Brand Devices [XLX]

D7075833210XL-X Plus 25 g
D7075822010XL-X 100 g
D7075822000XL-X 1oz/31 g
D7075821990XL-X 25 g
D7075821970XL-X 5 g

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