Omniloc™ Implant System
GUDID 00889024011069
ZIMMER DENTAL INC.
Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed| Primary Device ID | 00889024011069 |
| NIH Device Record Key | e4de67c4-d8cc-4c34-8644-def1e906350e |
| Commercial Distribution Discontinuation | 2016-03-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Omniloc™ Implant System |
| Version Model Number | 0618 |
| 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 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)854-7019 |
| zimmer.consumerrelations@zimmer.com |
Device Dimensions
| 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 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 | 00889024011069 [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 |
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
Moist Heat or Steam Sterilization
[00889024011069]
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 |
Trademark Results [Omniloc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNILOC 75786304 not registered Dead/Abandoned |
SULZER CALCITEK INC. 1999-08-26 |
 OMNILOC 75464115 not registered Dead/Abandoned |
Sulzer Calcitek Inc. 1998-04-07 |
 OMNILOC 74047307 1656734 Dead/Cancelled |
CALCITEK, INC. 1990-04-09 |
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