SAFE DENT

Basic Information

• Brand Name: SAFE DENT
• Primary DI: 00810339031428
• Version / Model: A90142M
• Company Name: BGSS Company Inc.
• Labeler DUNS: 828474952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-05-01
• Public Version: 1
• Public Version Date: 2024-05-09
• Public Version Status: New
• Public Device Record Key: a2b9fa27-fe20-45bc-ac30-12037e838f67

Device Description

A90142M FLOURIDE TRAY DUAL ARCH "medium" BAG 100

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMT	Tray, Fluoride, Disposable	Dental	872.6870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63350	Teeth whitening tray	A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810339031435	GS1	Case	10	In Commercial Distribution
Primary	00810339031428	GS1
Unit of Use	00810339031411	GS1