Ultrapro TX Cordless 5499

GUDID 00815967025924

Ultrapro Tx Cordless Prophy Motor Barrier Sleeves 500 ct

ULTRADENT PRODUCTS, INC.

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• Primary Device ID: 00815967025924
• NIH Device Record Key: da3ce244-dc9a-47eb-bcd7-5288ac563c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrapro TX Cordless
• Version Model Number: 5499
• Catalog Number: 5499
• 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: false
• Device Combination Product: false
• Single Use: true
• 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(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
• 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	00815967025924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151123

FDA Product Code

• PEM: Dental barriers and sleeves

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: 2023-06-05
• Device Publish Date: 2023-05-27

On-Brand Devices [Ultrapro TX Cordless]

• 69443136123930: Ultrapro Tx Cordless Prophy Sheath Kit
• 06944843655949: Ultrapro Tx Cordless Prophy Motor Kit Demo
• 06944843605975: Ultrapro Tx Cordless Prophy Motor Kit
• 00883205035479: Ultrapro Tx Cordless Prophy Plastic Cover of Handpiece Repair Part
• 00883205035462: Ultrapro Tx Cordless Prophy - Motor of Handpiece Repair Part
• 00883205035455: Ultrapro Tx Cordless Prophy PCB Board of Handpiece Repair Part
• 00883205035448: Ultrapro Tx Cordless Prophy Battery Repair Part
• 00883205035431: Ultrapro Tx Cordless Prophy Handpiece Repair Part
• 00883205035424: Ultrapro Tx Cordless Prophy Charger Base Replacement Part
• 00883205035417: Ultrapro Tx Cordless Prophy Foot Control Replacement Part
• 00883205035400: Ultrapro Tx Cordless Prophy O-Ring Replacement Pack
• 00883205035394: Ultrapro Tx Cordless Prophy Wall Charger Replacement Part
• 00815967025924: Ultrapro Tx Cordless Prophy Motor Barrier Sleeves 500 ct