Britedent

Basic Information

• Brand Name: Britedent
• Primary DI: D974BSI15011
• Version / Model: BSI-1501
• Company Name: Bright Supply, Inc.
• Labeler DUNS: 124117012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-02-22
• Public Version: 2
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: e9d56d2f-ca8f-4ac7-92d5-ae05fd651a71

Device Description

Micro Applicators Fine (1.5mm) Yellow

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: 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
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D974BSI15012	HIBCC	Ea	4	In Commercial Distribution
Primary	D974BSI15011	HIBCC
Unit of Use	D974BSI15010	HIBCC
Package	D974BSI15013	HIBCC	Ea	10	In Commercial Distribution