Twist™ Disposable Prophy Angles

Basic Information

• Brand Name: Twist™ Disposable Prophy Angles
• Primary DI: 10732224003334
• Version / Model: TPASC
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 1
• Public Version Date: 2022-10-07
• Public Version Status: New
• Public Device Record Key: da6da231-d286-45af-a730-8f18068cb44f

Device Description

Prophy Angle, Soft Cup, Gray

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: Yes
• 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
EFA	Handpiece, belt and/or gear driven, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50732224003332	GS1		12	In Commercial Distribution
Primary	10732224003334	GS1
Unit of Use	00732224003337	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973062	000