Permanent Crown A3

Basic Information

• Brand Name: Permanent Crown A3
• Primary DI: EBGOFLPCA301US1
• Version / Model: FLPCA301US
• 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: 2020-10-19
• Public Version: 3
• Public Version Date: 2021-09-15
• Public Version Status: Update
• Public Device Record Key: 04b464a1-6e39-4577-a2f6-98b09d944f38

Device Characteristics

• Single Use: Yes
• 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	EBGOFLPCA301US1	HIBCC
Package	EBGOFLPCA301US2	HIBCC	Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201668	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry