Zenith Implant Screw Mask ZEN

GUDID D820ZEN1

Dental Implant Screw Mask

DENALI CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin 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.