ultrapro Tx air 8505-

GUDID 00883205028068

Ultrapro Tx Air Blue Nose Cone Kit

ULTRADENT PRODUCTS, INC.

Dental power tool system handpiece, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic Dental delivery system instrument unit, pneumatic

• Primary Device ID: 00883205028068
• NIH Device Record Key: 782f9194-b915-4d6b-832f-92aca20b9829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ultrapro Tx air
• Version Model Number: 8505-
• Catalog Number: 8505-
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205028068 [Primary]
GS1	00883205033369 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070155

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

[00883205028068]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-07-02

On-Brand Devices [ultrapro Tx air]

• 00883205028082: Ultrapro Tx Air Blue Nose Cone Kit Demo
• 00883205028075: Ultrapro Tx Air Motor Kit Demo
• 00883205028068: Ultrapro Tx Air Blue Nose Cone Kit
• 00883205028051: Ultrapro Tx Air Pink Nose Cone Kit
• 00883205028044: Ultrapro Tx Air Green Nose Cone Kit
• 00883205028037: Ultrapro Tx Air Motor Kit
• 00883205028020: Ultrapro Tx Air Kit (Prophy Handpiece Motor with 3 Nose Cones)