Cagenix BarZero

GUDID 90860002441941

Milled denture teeth for dental restoration

CAGENIX, INC.

Resin artificial teeth
Primary Device ID90860002441941
NIH Device Record Keyfe49a851-704c-4221-b501-3979ab783a53
Commercial Distribution StatusIn Commercial Distribution
Brand NameCagenix BarZero
Version Model Number1000-05
Company DUNS030868250
Company NameCAGENIX, INC.
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 Batchfalse
Serial Numbertrue
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

Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com
Phone901-763-3784
Emailajschulter@cagenix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS190860002441941 [Primary]

FDA Product Code

ELMDenture, Plastic, Teeth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


[90860002441941]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-24
Device Publish Date2020-07-16

Devices Manufactured by CAGENIX, INC.

90860002441903 - Cagenix AccuFrame2020-07-24 Titanium framework for supporting multi implant restorations
90860002441910 - Cagenix AccuFrame IC2020-07-24 AccuFrame Titanium Framework to support a series of individual crowns
90860002441927 - Cagenix AccuFrame 3602020-07-24 AccuFrame Titanium Framework to support milled overlay
90860002441934 - Cagenix AccuFrame Overdenture2020-07-24 AccuFrame Titanium Framework to support milled overdenture
90860002441941 - Cagenix BarZero2020-07-24Milled denture teeth for dental restoration
90860002441941 - Cagenix BarZero2020-07-24 Milled denture teeth for dental restoration

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