CK BITE YELLOW ECONOMY 50095194

GUDID J014500951940

Wax, dental, intraoral

Kulzer GmbH

Bite registration rim wax
Primary Device IDJ014500951940
NIH Device Record Key1038e93c-962b-49b3-8f46-a3d93c9fd798
Commercial Distribution StatusIn Commercial Distribution
Brand NameCK BITE YELLOW ECONOMY
Version Model Number50095194
Catalog Number50095194
Company DUNS315666321
Company NameKulzer GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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
HIBCCJ014500951940 [Primary]

FDA Product Code

EGDWAX, DENTAL, INTRAORAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-10-30
Device Publish Date2016-09-15

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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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