ProUltra PiezoFlow PIEZOFLOWAP

GUDID D716PIEZOFLOWAP1

ProUltra PiezoFlow Acc Pack

TULSA DENTAL PRODUCTS LLC

Root canal ultrasonic irrigation handpiece tip

• Primary Device ID: D716PIEZOFLOWAP1
• NIH Device Record Key: 919beb5a-c164-44cc-9158-5c81f62765cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProUltra PiezoFlow
• Version Model Number: PIEZOFLOWAP
• Catalog Number: PIEZOFLOWAP
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716PIEZOFLOWAP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960889

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

Liquid Chemical

[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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[D716PIEZOFLOWAP1]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [ProUltra PiezoFlow]

• D716PIEZOFLOWSOLO1: ProUltra PiezoFlow SOLO
• D716PIEZOFLOWREFILL0: PiezoFlow Refill Pack
• D716PIEZOFLOWAP1: ProUltra PiezoFlow Acc Pack