TurboSENSOR +™ D660-O

GUDID 00810000521050

TurboSENSOR +™ Detachable 30K (Tangerine)

PARKELL, INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 00810000521050
• NIH Device Record Key: a915e8bf-817c-4153-ad5e-43ce5d32607e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TurboSENSOR +™
• Version Model Number: D660-O
• Catalog Number: D660-O
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000521050 [Primary]

FDA Product Code

• ELC: Scaler, Ultrasonic

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: 2023-10-30
• Device Publish Date: 2023-10-20

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• 00810000521050: TurboSENSOR +™ Detachable 30K (Tangerine)
• 00810000521043: TurboSENSOR +™ Detachable 30K (Midnight Blue)
• 00810000521036: TurboSENSOR +™ Detachable 30K (Electric Blue )
• 00810000520985: TurboSENSOR +™ Detachable 30K (Pearl)
• 00810000520909: TurboSENSOR +™ 30K Detachable Handpiece