VarseoSmile TriniQ BGTQA301

GUDID EBGOBGTQA3011

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Custom-made dental crown, polymer

• Primary Device ID: EBGOBGTQA3011
• NIH Device Record Key: 33d6f110-ea09-43d6-b94b-23d81aa66205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VarseoSmile TriniQ
• Version Model Number: BGTQA301
• Catalog Number: BGTQA301
• 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 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBGOBGTQA3011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233596

FDA Product Code

• PZY: Additively Manufactured, Preformed, Resin Denture Tooth

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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [VarseoSmile TriniQ]

• EBGO41186US1: 41186US
• EBGO41185US1: 41185US
• EBGO41184US1: 41184US
• EBGO41183US1: 41183US
• EBGO41182US1: 41182US
• EBGO41181US1: 41181US
• EBGO41180US1: 41180US
• EBGO41176US1: 41176US
• EBGO41175US1: 41175US
• EBGO41174US1: 41174US
• EBGO41173US1: 41173US
• EBGO41172US1: 41172US
• EBGO41171US1: 41171US
• EBGO41170US1: 41170US
• EBGOBGTQB1011: BGTQB101
• EBGOBGTQA3011: BGTQA301
• EBGOBGTQA2011: BGTQA201