Zirlux 9012234
GUDID H65890122340
Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Ankylos C/ 3.5 A
HENRY SCHEIN, 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 Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed| Primary Device ID | H65890122340 |
| NIH Device Record Key | 89f10f47-e2b4-4584-b91a-041704cdb6d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zirlux |
| Version Model Number | 9012234 |
| Catalog Number | 9012234 |
| Company DUNS | 012430880 |
| Company Name | HENRY SCHEIN, 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 | true |
| 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 |
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 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 |
|---|---|
| HIBCC | H65890122340 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141923
FDA Product Code
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
Moist Heat or Steam Sterilization
[H65890122340]
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 | 2016-09-24 |
On-Brand Devices [Zirlux]
| 00304040103968 | ZIRLUX ACETAL MILLING DISC G2 (BLEACHED) 71 x 20 mm |
| 00304040103951 | ZIRLUX ACETAL MILLING DISC B1 71 x 20mm B1 |
| 00304040103944 | ZIRLUX ACETAL MILLING DISC A1 71 x 20mm |
| 00304040070666 | Zirlux Acetal P1 98x25 |
| 00304040070659 | Zirlux Acetal P1 98x20 |
| 00304040070642 | Zirlux Acetal P1 98x15 |
| 00304040056639 | Zirlux Multi Anterior C2,98.5X25 |
| 00304040056622 | Zirlux Multi Anterior C2,98.5X22 |
| 00304040056615 | Zirlux Multi Anterior C2,98.5X20 |
| 00304040056608 | Zirlux Multi Anterior C2,98.5X18 |
| 00304040056592 | Zirlux Multi Anterior C2,98.5X16 |
| 00304040056585 | Zirlux Multi Anterior C2,98.5X14 |
| 00304040056578 | Zirlux Multi Anterior C2,98.5X12 |
| 00304040056561 | Zirlux Multi Anterior C2,98.5X10 |
| 00304040056554 | Zirlux Multi Anterior B2,98.5X25 |
| 00304040056547 | Zirlux Multi Anterior B2,98.5X22 |
| 00304040056530 | Zirlux Multi Anterior B2,98.5X20 |
| 00304040056523 | Zirlux Multi Anterior B2,98.5X18 |
| 00304040056516 | Zirlux Multi Anterior B2,98.5X16 |
| 00304040056509 | Zirlux Multi Anterior B2,98.5X14 |
| 00304040056493 | Zirlux Multi Anterior B2,98.5X12 |
| 00304040056486 | Zirlux Multi Anterior B2,98.5X10 |
| 00304040056479 | Zirlux Multi Anterior B1,98.5X25 |
| 00304040056462 | Zirlux Multi Anterior B1,98.5X22 |
| 00304040056455 | Zirlux Multi Anterior B1,98.5X20 |
| 00304040056448 | Zirlux Multi Anterior B1,98.5X18 |
| 00304040056431 | Zirlux Multi Anterior B1,98.5X16 |
| 00304040056424 | Zirlux Multi Anterior B1,98.5X14 |
| 00304040056417 | Zirlux Multi Anterior B1,98.5X12 |
| 00304040056400 | Zirlux Multi Anterior B1,98.5X10 |
| 00304040056394 | Zirlux Multi Anterior A3.5,98.5X25 |
| 00304040056387 | Zirlux Multi Anterior A3.5,98.5X22 |
| 00304040056370 | Zirlux Multi Anterior A3.5,98.5X20 |
| 00304040056363 | Zirlux Multi Anterior A3.5,98.5X18 |
| 00304040056356 | Zirlux Multi Anterior A3.5,98.5X16 |
| 00304040056349 | Zirlux Multi Anterior A3.5,98.5X14 |
| 00304040056332 | Zirlux Multi Anterior A3.5,98.5X12 |
| 00304040056325 | Zirlux Multi Anterior A3.5,98.5X10 |
| 00304040056318 | Zirlux Multi Anterior A3,98.5X25 |
| 00304040056301 | Zirlux Multi Anterior A3,98.5X22 |
| 00304040056295 | Zirlux Multi Anterior A3,98.5X20 |
| 00304040056288 | Zirlux Multi Anterior A3,98.5X18 |
| 00304040056271 | Zirlux Multi Anterior A3,98.5X16 |
| 00304040056264 | Zirlux Multi Anterior A3,98.5X14 |
| 00304040056257 | Zirlux Multi Anterior A3,98.5X12 |
| 00304040056240 | Zirlux Multi Anterior A3,98.5X10 |
| 00304040056233 | Zirlux Multi Anterior A2,98.5X25 |
| 00304040056226 | Zirlux Multi Anterior A2,98.5X22 |
| 00304040056219 | Zirlux Multi Anterior A2,98.5X20 |
| 00304040056202 | Zirlux Multi Anterior A2,98.5X18 |
Trademark Results [Zirlux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZIRLUX 86072262 4525459 Live/Registered |
HS TM, LLC 2013-09-23 |
 ZIRLUX 85213745 4046976 Live/Registered |
HS TM, LLC 2011-01-10 |
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