Safco Radiance™ Ultra Disposable Prophy Angle

Basic Information

• Brand Name: Safco Radiance™ Ultra Disposable Prophy Angle
• Primary DI: D72310254543
• Version / Model: 1025454
• Catalog Number: 1025454
• Company Name: SAFCO DENTAL SUPPLY CO.
• Labeler DUNS: 020417380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 89c3e254-3280-46c5-9e3c-18d3585c4b79

Device Description

Safco Radiance™ Ultra disposable prophy angle, firm cup, white, 100/box

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHK	CUP, PROPHYLAXIS	Dental	872.6290	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
Unit of Use	D72310254540	HIBCC
Primary	D72310254543	HIBCC