Denticator

Basic Information

• Brand Name: Denticator
• Primary DI: 00302735503109
• Version / Model: 550310
• Catalog Number: 550310
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Labeler DUNS: 006309355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-16
• Public Version: 2
• Public Version Date: 2022-11-11
• Public Version Status: Update
• Public Device Record Key: 162da20a-5548-4b72-833b-d56996003b9f

Device Description

Denticator DPA Original Green & Latex Free, Soft, Short, Web Green Cup & Mint Prophy Paste, Course - Combination Pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
EGS	Handpiece, contra- and right-angle attachment, dental	Dental	872.4200	1
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY	Dental	872.6030	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	No	Active
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	20302735503103	GS1	Case	9	In Commercial Distribution
Primary	00302735503109	GS1
Package	10302735503106	GS1	Box	100	In Commercial Distribution

Customer Contacts

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