Mondial 6i, A1 / T4, CE 66970463

GUDID J014669704630

Denture, plastic, teeth

Kulzer GmbH

Resin artificial teeth
Primary Device IDJ014669704630
NIH Device Record Key6a19c3c3-1dfb-4a5e-abfa-ed0beac8f4f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMondial 6i, A1 / T4, CE
Version Model Number66970463
Catalog Number66970463
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
HIBCCJ014669704630 [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

Devices Manufactured by Kulzer GmbH

J014660164550 - Starlight pro2026-02-05 Glare shield, orange
J014660573650 - Starlight pro2026-02-05 Light guide, 8mm, 70°
J014660968300 - Starlight pro2026-02-05 Starlight pro
J014660969290 - Starlight pro2026-02-05 Light guide, 8mm, 45°
J014660971690 - Starlight pro2026-02-05 Hand piece incl. rechargeable battery
J014660971700 - Starlight pro2026-02-05 Charger unit
J014661012160 - iCEM Universal Plus2026-01-23 iCEM Universal Plus Mixing Tips
J014661012170 - iCEM Universal Plus2026-01-23 iCEM Universal Plus Cement Opaque

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.