Preciso CAD EX003

GUDID 00817340022292

JENSEN INDUSTRIES INC.

Dental CAD/CAM system, laboratory

• Primary Device ID: 00817340022292
• NIH Device Record Key: e5343cc6-8f3e-4138-9bab-12fd729c9ab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Preciso CAD
• Version Model Number: Preciso CAD Software
• Catalog Number: EX003
• Company DUNS: 060018587
• Company Name: JENSEN INDUSTRIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817340022292 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

Devices Manufactured by JENSEN INDUSTRIES INC.

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• 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