Orthalgenat®

GUDID J011150520300

Orthalgenat® Duo, Impression material, berry / 20 x 1 kg

DENTAURUM GmbH & Co.KG

Alginate dental impression material

• Primary Device ID: J011150520300
• NIH Device Record Key: 60d5f756-55ee-4cf4-bd4a-b3d2bb4eb51d
• Commercial Distribution Discontinuation: 2020-03-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Orthalgenat®
• Version Model Number: 150-520-30
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 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 Agency	Device ID
HIBCC	J011150520300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942666

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-10
• Device Publish Date: 2017-05-13

On-Brand Devices [Orthalgenat®]

• J011150520300: Orthalgenat® Duo, Impression material, berry / 20 x 1 kg
• J011150509300: Orthalgenat® Duo, Impression material, berry / 9 x 1 kg
• J011150501300: Orthalgenat® Duo, Impression material, berry / 1 kg
• J011150520200: Orthalgenat® Duo, Impression material, mint
• J011150509200: Orthalgenat® Duo, Impression material, mint
• J011150501200: Orthalgenat® Duo, Impression material, mint