CHAIRSIDE

Basic Information

• Brand Name: CHAIRSIDE
• Primary DI: 00840481122132
• Version / Model: 09574
• Company Name: Zest Anchors, LLC
• Labeler DUNS: 078387192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-09-07
• Public Version: 1
• Public Version Date: 2023-09-15
• Public Version Status: New
• Public Device Record Key: 2b22100c-0582-4d90-bd20-d8c0ef244985

Device Description

CHAIRSIDE Block Out Material

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: Yes
• 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
EID	Syringe, Restorative And Impression Material	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57964	Gingiva bleaching protector	A non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10840481122139	GS1
Primary	00840481122132	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1.2	Milliliter