Omniloc™ Implant System

GUDID 00889024011076

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024011076
• NIH Device Record Key: 422fd951-7900-48e6-beb9-f23be86bc819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omniloc™ Implant System
• Version Model Number: 0619
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• DM Exempt: true
• 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(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024011076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900549

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

[00889024011076]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-23

On-Brand Devices [Omniloc™ Implant System]

• 00889024011380: 0872
• 00889024011106: 0648
• 00889024011090: 0647
• 00889024011083: 0646
• 00889024011076: 0619
• 00889024011069: 0618
• 00889024011052: 0617