VENUS DIAMOND PLT REFILL 1x10x0,25G A4 66039013

GUDID J014660390130

Dental Composite resin

Kulzer GmbH

Dental composite resin
Primary Device IDJ014660390130
NIH Device Record Keya2d9d4ef-870f-42a7-b90a-1e7a564b3cff
Commercial Distribution StatusIn Commercial Distribution
Brand NameVENUS DIAMOND PLT REFILL 1x10x0,25G A4
Version Model Number66039013
Catalog Number66039013
Company DUNS315666321
Company NameKulzer GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx
Phone+1(800)431-1785
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ014660390130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMATERIAL, TOOTH SHADE, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-10-30
Device Publish Date2016-09-23

Devices Manufactured by Kulzer GmbH

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J014661002690 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - MEDIUM
J014661002700 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - DARK
J014661002710 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - BLEACH
J014661002720 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - LIGHT
J014661002730 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - MEDIUM
J014661002740 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - DARK
J014661002750 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW PLT 20x0,20g - BLEACH

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