ODIPAL D2B185

GUDID 08435288422107

ODIPAL anterior Teeth Shade B1 , Mould 85

UNION DENTAL SA

Resin artificial teeth

• Primary Device ID: 08435288422107
• NIH Device Record Key: 2bce0704-2347-4d03-867d-d39be02cf32e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODIPAL
• Version Model Number: ANTERIOR TEETH B1/85
• Catalog Number: D2B185
• 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	08435288422107 [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: 2021-12-23
• Device Publish Date: 2021-12-15

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