Orthalgenat®

GUDID J011150509200

Orthalgenat® Duo, Impression material, mint

DENTAURUM GmbH & Co.KG

Alginate dental impression material
Primary Device IDJ011150509200
NIH Device Record Keyd4068fe1-de94-4c85-9476-270ec871bcb3
Commercial Distribution Discontinuation2023-12-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOrthalgenat®
Version Model Number150-509-20
Company DUNS315427286
Company NameDENTAURUM GmbH & Co.KG
Device Count1
DM Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com
Phone+1(800)523-3946
Emailinfo@dentaurum-us.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.
Special Storage Condition, SpecifyBetween 0 and 0 *Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ011150509200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-14
Device Publish Date2016-09-15

On-Brand Devices [Orthalgenat®]

J011150520300Orthalgenat® Duo, Impression material, berry / 20 x 1 kg
J011150509300Orthalgenat® Duo, Impression material, berry / 9 x 1 kg
J011150501300Orthalgenat® Duo, Impression material, berry / 1 kg
J011150520200Orthalgenat® Duo, Impression material, mint
J011150509200Orthalgenat® Duo, Impression material, mint
J011150501200Orthalgenat® Duo, Impression material, mint

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