Mondial 6i, A1 / L16, CE 66970474

GUDID J014669704740

Denture, plastic, teeth

Kulzer GmbH

Resin artificial teeth
Primary Device IDJ014669704740
NIH Device Record Keyd08837af-0117-4851-8e0e-791f0f4b27b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMondial 6i, A1 / L16, CE
Version Model Number66970474
Catalog Number66970474
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
HIBCCJ014669704740 [Primary]

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

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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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