Omniloc

GUDID 00889024011021

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024011021
• NIH Device Record Key: 43595da7-2a1e-440a-88e0-1ecd1712c3c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omniloc
• Version Model Number: 0601
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL 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(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

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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024011021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900694

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-05

Devices Manufactured by ZIMMER DENTAL INC.

• 00889024017788 - Driva: 2023-07-17 STEP DRILL,3.8/3.4MM,25MM
• 00889024015890 - Tapered SwissPlus® & SwisPlus®: 2023-06-29
• 00889024015630 - N/A: 2021-03-10
• 00889024010949 - Tapered Screw-Vent® Screw-Vent® AdVent® Tapered SwissPlus® Spline®: 2020-03-23
• 00889024010956 - Integral®: 2020-03-23
• 00889024010963 - Spline®: 2020-03-23
• 00889024010970 - Spline®: 2020-03-23
• 00889024011496 - N/A: 2020-03-23