Jensen FR Zirconia 40590

GUDID 00817340021790

JENSEN INDUSTRIES INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: 00817340021790
• NIH Device Record Key: 7ed85676-abca-4a2a-8f08-9e8eac1d9236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jensen FR Zirconia
• Version Model Number: Jensen FR Zr Unshaded 15.4mm Frame 6pk
• Catalog Number: 40590
• Company DUNS: 060018587
• Company Name: JENSEN INDUSTRIES INC.
• Device Count: 6
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817340021790 [Primary]
GS1	00817340022575 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112806

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-23

Devices Manufactured by JENSEN INDUSTRIES INC.

• 00817340025996 - MiYO Esthetic System: 2023-08-03
• 00817340025989 - MiYO Esthetic System: 2023-08-02
• 00817340026009 - MiYO Esthetic System: 2023-03-30
• 00817340025972 - MiYO Esthetic System: 2023-03-07
• 00817340025941 - MiYO Esthetic System: 2023-02-20
• 00817340025958 - MiYO Esthetic System: 2023-02-16
• 00817340025965 - MiYO Esthetic System: 2023-02-16
• 00817340025903 - MiYO Esthetic System: 2022-09-02