Enhance® PoGo® Polishing System

Basic Information

• Brand Name: Enhance® PoGo® Polishing System
• Primary DI: D002662025Y1
• Version / Model: 662025Y
• Catalog Number: 662025Y
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-13
• Public Version: 1
• Public Version Date: 2022-10-21
• Public Version Status: New
• Public Device Record Key: 56b21a77-7281-48cb-bc07-1a1a3e8b8e46

Device Description

Enhance® PoGo® Refill Package

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZP	INSTRUMENT, DIAMOND, DENTAL	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64617	Dental abrasive disk, single-use	A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D002662025Y1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10 Polishing Discs, 10 Polishing Points, 10 Polishing Cups

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry storage is recommended.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid direct sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use after expiration date.