EZ BITE BLOCK SOFT MOUTH PROP

Basic Information

• Brand Name: EZ BITE BLOCK SOFT MOUTH PROP
• Primary DI: 08800017902296
• Version / Model: BBS-6000L
• Company Name: DXM CO., LTD
• Labeler DUNS: 688797315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-18
• Public Version: 1
• Public Version Date: 2025-12-26
• Public Version Status: New
• Public Device Record Key: ff3173ba-0c42-4359-8ce5-f31cb0f4fe04

Device Description

Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity • Allows doctors to have an additional hand • Jagged biting surface to minimize slipping • Ideal for keeping upper and lower arch of patient's mouth during oral treatments • Enhances patient's comfort avoiding patient fatigue • Disposable, Single Use Only. Not Autoclavable. • Dual injected with silicone layer for improved comfort and stability

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: No
• 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
BRW	Protector, Dental	Anesthesiology	868.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66751	Dental suction protective mouthpiece	A prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08800017902319	GS1	Zip bag	50	In Commercial Distribution
Primary	08800017902296	GS1
Package	08800017902333	GS1	Zip bag	100	In Commercial Distribution