ProUltra PiezoFlow PIEZOFLOWSOLO

GUDID D716PIEZOFLOWSOLO1

ProUltra PiezoFlow SOLO

TULSA DENTAL PRODUCTS LLC

Dental torque wrench

• Primary Device ID: D716PIEZOFLOWSOLO1
• NIH Device Record Key: a8616ded-6054-4ef2-b3b2-97dafa1f4bf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProUltra PiezoFlow
• Version Model Number: PIEZOFLOWSOLO
• Catalog Number: PIEZOFLOWSOLO
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716PIEZOFLOWSOLO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960889

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: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [ProUltra PiezoFlow]

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