Ultrawave 4308

GUDID 00883205019202

Ultrawave Bottle cap

ULTRADENT PRODUCTS, INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 00883205019202
• NIH Device Record Key: 9fb9e50e-6db2-4ab3-8862-62522faeac3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrawave
• Version Model Number: 4308
• Catalog Number: 4308
• 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: 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(801)572-4200
• Email: customerservice@ultradent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205019202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050895

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-17

On-Brand Devices [Ultrawave]

• 00883205019202: Ultrawave Bottle cap
• 00883205019196: Ultrawave NitiSonic Tip and Bottle connector Kit