ultrapro Tx air 8505-

GUDID 00883205028068

Ultrapro Tx Air Blue Nose Cone Kit

ULTRADENT PRODUCTS, INC.

Dental power tool system handpiece, 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)