ORTOLUX TOP M3

GUDID 08435288400839

PREFORMED DENTURE TEETH. POSTERIOR TEETH - SET OF 8

UNION DENTAL SA

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• Primary Device ID: 08435288400839
• NIH Device Record Key: b3873b99-2731-4fe6-a787-f29102de9d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTOLUX TOP
• Version Model Number: POSTERIOR TEETH 1x8
• Catalog Number: M3
• Company DUNS: 462114760
• Company Name: UNION DENTAL SA
• 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: 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	08435288400839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070591

FDA Product Code

• ELM: Denture, Plastic, Teeth

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: 2021-12-17
• Device Publish Date: 2017-02-13

On-Brand Devices [ORTOLUX TOP]

• 08435288400839: PREFORMED DENTURE TEETH. POSTERIOR TEETH - SET OF 8
• 08435288400631: PREFORMED DENTURE TEETH. FRONT TEETH - SET OF 6