ELEDENT M9

GUDID 08435288400891

PREFORMED DENTURE TEETH. POSTERIOR TEETH - SET OF 8

UNION DENTAL SA

Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth

• Primary Device ID: 08435288400891
• NIH Device Record Key: ecee97d0-3855-46da-aff5-6444aaf7918c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEDENT
• Version Model Number: POSTERIOR TEETH 1x8
• Catalog Number: M9
• 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	08435288400891 [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 [ELEDENT]

• 08435288400891: PREFORMED DENTURE TEETH. POSTERIOR TEETH - SET OF 8
• 08435288400693: PREFORMED DENTURE TEETH. FRONT TEETH - SET OF 6