Zenith Implant Screw Mask ZEN

GUDID D820ZEN1

Dental Implant Screw Mask

DENALI CORPORATION

Dental composite resin

• Primary Device ID: D820ZEN1
• NIH Device Record Key: 8d0bd6ab-2ee2-46a6-a51e-7d421ccc8f25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zenith Implant Screw Mask
• Version Model Number: ZEN1
• Catalog Number: ZEN
• Company DUNS: 191036107
• Company Name: DENALI CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D820ZEN0 [Primary]
HIBCC	D820ZEN1 [Package]; Contains: D820ZEN0; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

Devices Manufactured by DENALI CORPORATION

• D820ZEN1 - Zenith Implant Screw Mask: 2023-06-21Dental Implant Screw Mask
• D820ZEN1 - Zenith Implant Screw Mask: 2023-06-21 Dental Implant Screw Mask
• D820ACOREEOW0 - AuraCore Buildup Material: 2018-07-06 Core Buildup Material, Dental.
• D820ACORENOW0 - AuraCore Buildup Material: 2018-07-06 Core Buildup Material, Dental.
• D820ALAYNT0 - AuraLay Pit & Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
• D820ALAYNT3ML0 - AuraLay Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
• D820ALAYOW0 - AuraLay Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
• D820ALAYOW3ML0 - AuraLay Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.
• D820ALAYXFNT0 - AuraLay XF Pit and Fissure Sealant: 2018-07-06 Pit and Fissure Sealant, Dental.