VarseoSmile Crown plus

Basic Information

• Brand Name: VarseoSmile Crown plus
• Primary DI: EBGO41107US1
• Version / Model: 41107US
• Catalog Number: 41107US
• Company Name: BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG
• Labeler DUNS: 316483072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 3
• Public Version Date: 2021-09-15
• Public Version Status: Update
• Public Device Record Key: bee3ad60-c83d-48a7-99e2-5012bf224415

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38595	Custom-made dental crown, polymer	A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBGO41107US1	HIBCC
Package	EBGO41107US2	HIBCC	Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201668	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius