Endo-Eze AET Contra Angle 3219-

GUDID 00883205021076

ENDO CONTRA ANGLE LOANER

ULTRADENT PRODUCTS, INC.

Dental laboratory drilling system motor

• Primary Device ID: 00883205021076
• NIH Device Record Key: f26abc78-d737-4747-805e-0c128675cd42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Eze AET Contra Angle
• Version Model Number: 3219-
• Catalog Number: 3219-
• 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	00883205021076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992380

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[00883205021076]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-05
• Device Publish Date: 2018-09-04

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