Zirlux 9012237

GUDID H65890122370

Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Ankylos C/ 7.0 D

HENRY SCHEIN, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: H65890122370
• NIH Device Record Key: c8bb9423-d1b7-4045-82db-2cf6e6ce671e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zirlux
• Version Model Number: 9012237
• Catalog Number: 9012237
• 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	H65890122370 [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

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

Moist Heat or Steam Sterilization

[H65890122370]

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