ST Basic 6, CE 66030384

GUDID J014660303840

denture,plastic,teeth

Kulzer GmbH

Resin artificial teeth
Primary Device IDJ014660303840
NIH Device Record Key1fa642c5-5999-4d3d-91f5-af7531505ca8
Commercial Distribution StatusIn Commercial Distribution
Brand NameST Basic 6, CE
Version Model Number66030384
Catalog Number66030384
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
HIBCCJ014660303840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, plastic, teeth

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 Date2016-09-15

Devices Manufactured by Kulzer GmbH

J01466081670 - Dima2024-11-07 dima Print Denture - Light Reddish Pink
J01466081673 - Dima2024-11-07 dima Print Denture - Dark Pink
J01466081678 - Dima2024-11-07 dima Print Denture Teeth - B1
J01466087415 - Dima2024-11-07 dima Print Denture Teeth - BL1
J014661002680 - VENUS Diamond FLOW2024-11-01 VENUS Diamond FLOW SYR 1 x 1,8G - LIGHT
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

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