Enhance® PoGo® Polishing System 662010Y

GUDID D002662010Y1

Enhance PoGo Disc Refill - Export Package

DENTSPLY INTERNATIONAL INC.

Dental abrasive disk, reusable

• Primary Device ID: D002662010Y1
• NIH Device Record Key: 9a89bbe0-7ddf-4b56-8344-21956534e9af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enhance® PoGo® Polishing System
• Version Model Number: 662010Y
• Catalog Number: 662010Y
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 30
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D002662010Y0 [Unit of Use]
HIBCC	D002662010Y1 [Primary]

FDA Product Code

• DZP: INSTRUMENT, DIAMOND, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2019-04-02

On-Brand Devices [Enhance® PoGo® Polishing System]

• D002662023Y1: Enhance PoGo Polishing System Cup Refill - Export Only
• D0026620231: Enhance PoGo Polishing System Cup Refill
• D002662022Y1: Enhance PoGo Point Refill Package (Export Only)
• D002662010Y1: Enhance PoGo Disc Refill - Export Package
• D0026240241: Enhance PoGo Sample Package
• D0026620222: PoGo® One Step Diamond Micro-Polisher - Polishing Point Refill Package (40)
• D0026620201: Enhance® PoGo® COMPLETE Kit
• D0026620101: PoGo One Step Diamond Micro-Polisher, DISC Refill Package (40)
• D002662025Y1: Enhance® PoGo® Refill Package
• D0026620241: Enhance® PoGo® Sample Package