ORTOLUX TOP D3B221

GUDID 08435288432472

ORTOLUX TOP anterior Teeth Shade B2, Mould 21

UNION DENTAL SA

Resin artificial teeth

• Primary Device ID: 08435288432472
• NIH Device Record Key: bc2cac47-2e64-459d-a893-77049c532236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTOLUX TOP
• Version Model Number: ANTERIOR TEETH B2/21
• Catalog Number: D3B221
• 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	08435288432472 [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: 2024-09-26
• Device Publish Date: 2024-09-18

On-Brand Devices [ORTOLUX TOP]

• 08435288400839: PREFORMED DENTURE TEETH. POSTERIOR TEETH - SET OF 8
• 08435288400631: PREFORMED DENTURE TEETH. FRONT TEETH - SET OF 6
• 08435288439709: ORTOLUX TOP anterior Teeth Shade 77, Mould 3R
• 08435288439693: ORTOLUX TOP anterior Teeth Shade 77, Mould 226
• 08435288439686: ORTOLUX TOP anterior Teeth Shade 77, Mould 13
• 08435288439679: ORTOLUX TOP anterior Teeth Shade 77, Mould 3NN
• 08435288439662: ORTOLUX TOP anterior Teeth Shade 77, Mould 1NN
• 08435288439655: ORTOLUX TOP anterior Teeth Shade 77, Mould 3PP
• 08435288439648: ORTOLUX TOP anterior Teeth Shade 77, Mould 2DD
• 08435288439631: ORTOLUX TOP anterior Teeth Shade 77, Mould 9
• 08435288439624: ORTOLUX TOP anterior Teeth Shade 77, Mould 5
• 08435288439617: ORTOLUX TOP anterior Teeth Shade 77, Mould 4
• 08435288439600: ORTOLUX TOP anterior Teeth Shade 77, Mould 23
• 08435288439594: ORTOLUX TOP anterior Teeth Shade 77, Mould 20
• 08435288439587: ORTOLUX TOP anterior Teeth Shade 77, Mould 1H
• 08435288439570: ORTOLUX TOP anterior Teeth Shade 77, Mould 21
• 08435288439563: ORTOLUX TOP anterior Teeth Shade 77, Mould 3P
• 08435288439556: ORTOLUX TOP anterior Teeth Shade 77, Mould 2P
• 08435288439549: ORTOLUX TOP anterior Teeth Shade 77, Mould 3N
• 08435288439532: ORTOLUX TOP anterior Teeth Shade 77, Mould 2N
• 08435288439525: ORTOLUX TOP anterior Teeth Shade 77, Mould 1N
• 08435288439518: ORTOLUX TOP anterior Teeth Shade 77, Mould 136
• 08435288439501: ORTOLUX TOP anterior Teeth Shade 77, Mould 4H
• 08435288439495: ORTOLUX TOP anterior Teeth Shade 77, Mould A26
• 08435288439488: ORTOLUX TOP anterior Teeth Shade 77, Mould A25
• 08435288439471: ORTOLUX TOP anterior Teeth Shade 77, Mould 15
• 08435288439464: ORTOLUX TOP anterior Teeth Shade 77, Mould 90
• 08435288439457: ORTOLUX TOP anterior Teeth Shade 77, Mould 3D
• 08435288439440: ORTOLUX TOP anterior Teeth Shade 77, Mould 2D
• 08435288439433: ORTOLUX TOP anterior Teeth Shade 77, Mould 3M
• 08435288439426: ORTOLUX TOP anterior Teeth Shade 77, Mould 62
• 08435288439419: ORTOLUX TOP anterior Teeth Shade 69, Mould 3R
• 08435288439402: ORTOLUX TOP anterior Teeth Shade 69, Mould 226
• 08435288439396: ORTOLUX TOP anterior Teeth Shade 69, Mould 13
• 08435288439389: ORTOLUX TOP anterior Teeth Shade 69, Mould 3NN
• 08435288439372: ORTOLUX TOP anterior Teeth Shade 69, Mould 1NN
• 08435288439365: ORTOLUX TOP anterior Teeth Shade 69, Mould 3PP
• 08435288439358: ORTOLUX TOP anterior Teeth Shade 69, Mould 2DD
• 08435288439341: ORTOLUX TOP anterior Teeth Shade 69, Mould 9
• 08435288439334: ORTOLUX TOP anterior Teeth Shade 69, Mould 5
• 08435288439327: ORTOLUX TOP anterior Teeth Shade 69, Mould 4
• 08435288439310: ORTOLUX TOP anterior Teeth Shade 69, Mould 23
• 08435288439303: ORTOLUX TOP anterior Teeth Shade 69, Mould 20
• 08435288439297: ORTOLUX TOP anterior Teeth Shade 69, Mould 1H
• 08435288439280: ORTOLUX TOP anterior Teeth Shade 69, Mould 21
• 08435288439273: ORTOLUX TOP anterior Teeth Shade 69, Mould 3P
• 08435288439266: ORTOLUX TOP anterior Teeth Shade 69, Mould 2P
• 08435288439259: ORTOLUX TOP anterior Teeth Shade 69, Mould 3N
• 08435288439242: ORTOLUX TOP anterior Teeth Shade 69, Mould 2N
• 08435288439235: ORTOLUX TOP anterior Teeth Shade 69, Mould 1N