VarseoSmile Crown plus 41111US

GUDID EBGO41111US1

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Custom-made dental crown, polymer

• Primary Device ID: EBGO41111US1
• NIH Device Record Key: f348a7ee-3f2b-4cdd-bc45-8fd38d2219c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VarseoSmile Crown plus
• Version Model Number: 41111US
• Catalog Number: 41111US
• 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: false
• 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

• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBGO41111US1 [Primary]
HIBCC	EBGO41111US2 [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: 2020-07-17

On-Brand Devices [VarseoSmile Crown plus]

• EBGO41123: 41123US
• EBGO41122: 41122US
• EBGO41121: 41121US
• EBGO41120: 41120US
• EBGO41119: 41119US
• EBGO41118: 41118US
• EBGO41117: 41117US
• EBGO41113: 41113US
• EBGO41112: 41112US
• EBGO41111: 41111US
• EBGO41110: 41110US
• EBGO41109: 41109US
• EBGO41108: 41108US
• EBGO41107: 41107US
• EBGO41123US1: 41123US
• EBGO41122US1: 41122US
• EBGO41121US1: 41121US
• EBGO41120US1: 41120US
• EBGO41119US1: 41119US
• EBGO41118US1: 41118US
• EBGO41117US1: 41117US
• EBGO41113US1: 41113US
• EBGO41112US1: 41112US
• EBGO41111US1: 41111US
• EBGO41110US1: 41110US
• EBGO41109US1: 41109US
• EBGO41108US1: 41108US
• EBGO41107US1: 41107US
• EBGO41124US1: 41124US
• EBGO41114US1: 41114US