Philips Zoom!

Basic Information

• Brand Name: Philips Zoom!
• Primary DI: 00075020034991
• Version / Model: DIS556/01
• Company Name: Discus Dental, LLC
• Labeler DUNS: 831726109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 9
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 653f9165-33d6-410a-8c85-faa5381775df

Device Description

Tooth Whitening Procedure Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LBH	VARNISH, CAVITY	Dental	872.3260	2

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	00075020034991	GS1
Unit of Use	00075020065773	GS1

Premarket Submissions

Submission Number	Supplement Number
K062176	000