ProUltra SINE PUSINE1-6

GUDID D716PUSINE161

ProUltra SINE Tips 1-6

TULSA DENTAL PRODUCTS LLC

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: D716PUSINE161
• NIH Device Record Key: 96cfccb7-b1c0-4d7b-8ac9-60f51c6babce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProUltra SINE
• Version Model Number: PUSINE1-6
• Catalog Number: PUSINE1-6
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 6
• 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: 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: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716PUSINE161 [Primary]
HIBCC	PUSINE160 [Unit of Use]

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

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

[D716PUSINE161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-01-05
• Device Publish Date: 2016-11-11

On-Brand Devices [ProUltra SINE]

• D716PUSINE61: ProUltra SINE Tip #6
• D716PUSINE51: ProUltra SINE Tip #5
• D716PUSINE41: ProUltra SINE Tip #4
• D716PUSINE31: ProUltra SINE Tip #3
• D716PUSINE161: ProUltra SINE Tips 1-6