ODIPAL D2D469

GUDID 08435288425221

ODIPAL anterior Teeth Shade D4 , Mould 69

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

• Primary Device ID: 08435288425221
• NIH Device Record Key: d56bf536-2fd2-409b-9c33-57183ed8d31e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODIPAL
• Version Model Number: ANTERIOR TEETH D4/69
• Catalog Number: D2D469
• 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	08435288425221 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-19
• Device Publish Date: 2022-01-11

On-Brand Devices [ODIPAL]

• 08435288420943: ODIPAL anterior Teeth Shade A2 , Mould U29
• 08435288420936: ODIPAL anterior Teeth Shade A2 , Mould U19
• 08435288420929: ODIPAL anterior Teeth Shade A2 , Mould U18
• 08435288420912: ODIPAL anterior Teeth Shade A2 , Mould U17
• 08435288420905: ODIPAL anterior Teeth Shade A2 , Mould U16
• 08435288420899: ODIPAL anterior Teeth Shade A2 , Mould U15
• 08435288420882: ODIPAL anterior Teeth Shade A2 , Mould U14
• 08435288420875: ODIPAL anterior Teeth Shade A2 , Mould U13
• 08435288420868: ODIPAL anterior Teeth Shade A2 , Mould U12
• 08435288420851: ODIPAL anterior Teeth Shade A2 , Mould U10
• 08435288420844: ODIPAL anterior Teeth Shade A2 , Mould 87
• 08435288420837: ODIPAL anterior Teeth Shade A2 , Mould 86
• 08435288420820: ODIPAL anterior Teeth Shade A2 , Mould 85
• 08435288420813: ODIPAL anterior Teeth Shade A2 , Mould 84
• 08435288420806: ODIPAL anterior Teeth Shade A2 , Mould 83
• 08435288420790: ODIPAL anterior Teeth Shade A2 , Mould 82
• 08435288420783: ODIPAL anterior Teeth Shade A2 , Mould 80
• 08435288420776: ODIPAL anterior Teeth Shade A2 , Mould 78
• 08435288420769: ODIPAL anterior Teeth Shade A2 , Mould 75
• 08435288420752: ODIPAL anterior Teeth Shade A2 , Mould 74
• 08435288420745: ODIPAL anterior Teeth Shade A2 , Mould 69
• 08435288420738: ODIPAL anterior Teeth Shade A2 , Mould 68
• 08435288420721: ODIPAL anterior Teeth Shade A2 , Mould 58
• 08435288420714: ODIPAL anterior Teeth Shade A2 , Mould 57
• 08435288420707: ODIPAL anterior Teeth Shade A2 , Mould 56
• 08435288420691: ODIPAL anterior Teeth Shade A2 , Mould 55
• 08435288420684: ODIPAL anterior Teeth Shade A2 , Mould 54
• 08435288420677: ODIPAL anterior Teeth Shade A2 , Mould 53
• 08435288420660: ODIPAL anterior Teeth Shade A2 , Mould 52
• 08435288420653: ODIPAL anterior Teeth Shade A2 , Mould 51
• 08435288420646: ODIPAL anterior Teeth Shade A2 , Mould 50
• 08435288420622: ODIPAL anterior Teeth Shade A1 , Mould U29
• 08435288420615: ODIPAL anterior Teeth Shade A1 , Mould U19
• 08435288420608: ODIPAL anterior Teeth Shade A1 , Mould U18
• 08435288420592: ODIPAL anterior Teeth Shade A1 , Mould U17
• 08435288420585: ODIPAL anterior Teeth Shade A1 , Mould U16
• 08435288420578: ODIPAL anterior Teeth Shade A1 , Mould U15
• 08435288420561: ODIPAL anterior Teeth Shade A1 , Mould U14
• 08435288420554: ODIPAL anterior Teeth Shade A1 , Mould U13
• 08435288420547: ODIPAL anterior Teeth Shade A1 , Mould U12
• 08435288420530: ODIPAL anterior Teeth Shade A1 , Mould U10
• 08435288420523: ODIPAL anterior Teeth Shade A1 , Mould 87
• 08435288420516: ODIPAL anterior Teeth Shade A1 , Mould 86
• 08435288420509: ODIPAL anterior Teeth Shade A1 , Mould 85
• 08435288420493: ODIPAL anterior Teeth Shade A1 , Mould 84
• 08435288420486: ODIPAL anterior Teeth Shade A1 , Mould 83
• 08435288420479: ODIPAL anterior Teeth Shade A1 , Mould 82
• 08435288420462: ODIPAL anterior Teeth Shade A1 , Mould 80
• 08435288420455: ODIPAL anterior Teeth Shade A1 , Mould 78
• 08435288420448: ODIPAL anterior Teeth Shade A1 , Mould 75