Richwil Crown & Bridge Remover

Basic Information

• Brand Name: Richwil Crown & Bridge Remover
• Primary DI: D248338001
• Version / Model: 33800
• Company Name: HAGER WORLDWIDE, INC.
• Labeler DUNS: 009277971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: d0c6f705-516f-4200-b56a-c21ecba49247

Device Description

Crown and bridge remover

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIS	REMOVER, CROWN	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66364	Dental prosthesis removal adhesive resin	An adherent dental material intended to be used by a dental professional to perform patient-assisted removal of a permanent or temporary cemented dental prosthesis (e.g., crown, bridge). It is typically in the form of a resin cube which, when moistened and bitten down upon, adheres to the prosthesis and the occlusal surface of opposing dentition, whereupon subsequent mouth opening by the patient detaches the prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D248338001	HIBCC
Unit of Use	D248338000	HIBCC

Customer Contacts

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