Perio Sciences Replacement Tooth Whitening Pens

Basic Information

• Brand Name: Perio Sciences Replacement Tooth Whitening Pens
• Primary DI: 00353238106212
• Version / Model: 10621
• Company Name: Perio Sciences, LLC
• Labeler DUNS: 961798605
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-08
• Public Version: 1
• Public Version Date: 2024-02-16
• Public Version Status: New
• Public Device Record Key: ec50bbf2-1302-4486-973c-2f231b33381d

Device Description

Replacement pens for the Perio Sciences LED Tooth Whitener Device. The composition is used in the whitening tray which encloses the teeth during the whitening procedure.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
MAU	Eraser, Dental Stain	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46432	Teeth whitening kit	A collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00353238106212	GS1