Celtra® 5365400406

GUDID EDD153654004060

DeguDent GmbH

Dental appliance fabrication material, ceramic

• Primary Device ID: EDD153654004060
• NIH Device Record Key: 40b27d6f-fe6d-44a7-883d-5439fb2d636d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celtra®
• Version Model Number: CELTRA PRESS MO 0, 3x6g
• Catalog Number: 5365400406
• Company DUNS: 329532225
• Company Name: DeguDent GmbH
• Device Count: 3
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +49061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com
• Phone: +011(49)061815950
• Email: info.degudent-de@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDD153654004060 [Primary]
HIBCC	EDD153654004068 [Unit of Use]

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-21
• Device Publish Date: 2019-03-13

On-Brand Devices [Celtra®]

• EDD153654004070: CELTRA PRESS MO 0, 5x3g
• EDD153654004060: CELTRA PRESS MO 0, 3x6g
• EDD153654112558: CELTRA Duo HT B1, C14, 4ST
• EDD153654111858: CELTRA Duo LT BL3, C14, 4ST
• EDD153654110558: CELTRA Duo LT B1, C14, 4ST