SprintRay Crown SRI0205040

GUDID EBGOSRI02050402

BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer

• Primary Device ID: EBGOSRI02050402
• NIH Device Record Key: 2ed8a468-0418-4036-a771-8c1d31896136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SprintRay Crown
• Version Model Number: SRI0205040
• Catalog Number: SRI0205040
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBGOSRI02050402 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [SprintRay Crown]

• EBGOSRI02050462: SRI0205046
• EBGOSRI02050452: SRI0205045
• EBGOSRI02050442: SRI0205044
• EBGOSRI02050432: SRI0205043
• EBGOSRI02050422: SRI0205042
• EBGOSRI02050412: SRI0205041
• EBGOSRI02050402: SRI0205040