Temporary CB BL FLTCBL01US

GUDID FLTCBL01US1

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: FLTCBL01US1
• NIH Device Record Key: d6b8c856-1464-458c-9672-90ea685e6da6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporary CB BL
• Version Model Number: FLTCBL01US
• Catalog Number: FLTCBL01US
• Company DUNS: 316483072
• Company Name: BEGO Bremer Goldschlägerei Wilh. Herbst 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: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com
• Phone: +4942120280
• Email: info@bego.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry
• Special Storage Condition, Specify: Between 0 and 0 *Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	FLTCBL01US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193553

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2023-05-30
• Device Publish Date: 2023-05-22

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• EBGO41172US1 - VarseoSmile TriniQ: 2023-12-15
• EBGO41173US1 - VarseoSmile TriniQ: 2023-12-15
• EBGO41174US1 - VarseoSmile TriniQ: 2023-12-15
• EBGO41175US1 - VarseoSmile TriniQ: 2023-12-15
• EBGO41176US1 - VarseoSmile TriniQ: 2023-12-15
• EBGO41180US1 - VarseoSmile TriniQ: 2023-12-15