Permanent Crown B1

GUDID EBGOFLPCB101US1

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Custom-made dental crown, polymer

• Primary Device ID: EBGOFLPCB101US1
• NIH Device Record Key: d2fb5824-aa93-497b-9a50-636931bbff10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Permanent Crown B1
• Version Model Number: FLPCB101US
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBGOFLPCB101US1 [Primary]
HIBCC	EBGOFLPCB101US2 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201668

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-15
• Device Publish Date: 2020-10-19

On-Brand Devices [Permanent Crown B1]

• EBGOFLPCB101: FLPCB101US
• EBGOFLPCB101US1: FLPCB101US