Britedent

Basic Information

• Brand Name: Britedent
• Primary DI: D974BSIRHB1
• Version / Model: BSI-RHB
• Company Name: Bright Supply, Inc.
• Labeler DUNS: 124117012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2024-03-12
• Public Version: 1
• Public Version Date: 2024-03-20
• Public Version Status: New
• Public Device Record Key: a3c863f8-0bfd-43fa-a4cd-97dde143cf1a

Device Description

Blue Retainer Box ventilated.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JER	Cleaner, Denture, Mechanical	Dental	872.3530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35893	Denture cleaning container	A non-powered receptacle intended to be used to clean/rinse a denture or similar dental prosthesis (e.g., a bridge). It is in the form of a container intended to hold the denture, typically with a denture cleansing solution, which may be manually agitated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D974BSIRHB2	HIBCC	Box	24	In Commercial Distribution
Primary	D974BSIRHB1	HIBCC
Unit of Use	D974BSIRHB0	HIBCC