Enhance® PoGo® Polishing System 662025Y

GUDID D002662025Y1

Enhance® PoGo® Refill Package

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D002662025Y1
• NIH Device Record Key: 56b21a77-7281-48cb-bc07-1a1a3e8b8e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enhance® PoGo® Polishing System
• Version Model Number: 662025Y
• Catalog Number: 662025Y
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Dry storage is recommended.
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D002662025Y1 [Primary]

FDA Product Code

• DZP: INSTRUMENT, DIAMOND, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-10-13

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