SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack

Basic Information

• Brand Name: SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack
• Primary DI: 00840161311764
• Version / Model: 50Z970SMPL-US
• Company Name: ZIRC DENTAL PRODUCTS, INC.
• Labeler DUNS: 064783913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: 2d8dba9b-0f1c-42ec-a0b1-d6b31c702f0c

Device Description

SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
DYN	Mouthpiece, Saliva Ejector	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65514	Dental suction system cannula soft tip	A spongy tubular device designed to be fitted on the distal end of a dental suction cannula to provide intraoral cushioning and prevent intraoral tissue damage and irritation during a dental procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840161311764	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	15.5	Millimeter
Height	25.4	Millimeter