10TEMP RGW-A3-16

GUDID 08435288481623

10TEMP RATAVA DISC 5 LAYERS COLOR A3 98,5/16mm

UNION DENTAL SA

Dental crown/bridge, temporary Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge

• Primary Device ID: 08435288481623
• NIH Device Record Key: ea094053-ed0e-49ce-8ce6-cd37ba1ff573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10TEMP
• Version Model Number: DISC A3 5 LAYERS 98,5/16mm
• Catalog Number: RGW-A3-16
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435288481623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150432

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [10TEMP]

• 08435288480015: 10TEMP RATAVA DISC 10 LAYERS COLOR A2 98,5/20mm
• 08435288480008: 10TEMP RATAVA DISC 10 LAYERS COLOR A1 98,5/20mm
• 08435288480039: 10TEMP RATAVA DISC 10 LAYERS COLOR A3,5 98,5/20mm
• 08435288480596: 10TEMP RATAVA DISC 10 LAYERS COLOR BL4 98,5/25mm
• 08435288480589: 10TEMP RATAVA DISC 10 LAYERS COLOR BL3 98,5/25mm
• 08435288480572: 10TEMP RATAVA DISC 10 LAYERS COLOR BL2 98,5/25mm
• 08435288480565: 10TEMP RATAVA DISC 10 LAYERS COLOR BL1 98,5/25mm
• 08435288480558: 10TEMP RATAVA DISC 10 LAYERS COLOR D4 98,5/25mm
• 08435288480541: 10TEMP RATAVA DISC 10 LAYERS COLOR D3 98,5/25mm
• 08435288480534: 10TEMP RATAVA DISC 10 LAYERS COLOR D2 98,5/25mm
• 08435288480527: 10TEMP RATAVA DISC 10 LAYERS COLOR C4 98,5/25mm
• 08435288480510: 10TEMP RATAVA DISC 10 LAYERS COLOR C3 98,5/25mm
• 08435288480503: 10TEMP RATAVA DISC 10 LAYERS COLOR C2 98,5/25mm
• 08435288480497: 10TEMP RATAVA DISC 10 LAYERS COLOR C1 98,5/25mm
• 08435288480480: 10TEMP RATAVA DISC 10 LAYERS COLOR B4 98,5/25mm
• 08435288480473: 10TEMP RATAVA DISC 10 LAYERS COLOR B3 98,5/25mm
• 08435288480466: 10TEMP RATAVA DISC 10 LAYERS COLOR B2 98,5/25mm
• 08435288480459: 10TEMP RATAVA DISC 10 LAYERS COLOR B1 98,5/25mm
• 08435288480442: 10TEMP RATAVA DISC 10 LAYERS COLOR A4 98,5/25mm
• 08435288480435: 10TEMP RATAVA DISC 10 LAYERS COLOR A3,5 98,5/25mm
• 08435288480428: 10TEMP RATAVA DISC 10 LAYERS COLOR A3 98,5/25mm
• 08435288480411: 10TEMP RATAVA DISC 10 LAYERS COLOR A2 98,5/25mm
• 08435288480404: 10TEMP RATAVA DISC 10 LAYERS COLOR A1 98,5/25mm
• 08435288480398: 10TEMP RATAVA DISC 10 LAYERS COLOR BL4 95/20mm
• 08435288480381: 10TEMP RATAVA DISC 10 LAYERS COLOR BL3 95/20mm
• 08435288480374: 10TEMP RATAVA DISC 10 LAYERS COLOR BL2 95/20mm
• 08435288480367: 10TEMP RATAVA DISC 10 LAYERS COLOR BL1 95/20mm
• 08435288480350: 10TEMP RATAVA DISC 10 LAYERS COLOR D4 95/20mm
• 08435288480343: 10TEMP RATAVA DISC 10 LAYERS COLOR D3 95/20mm
• 08435288480336: 10TEMP RATAVA DISC 10 LAYERS COLOR D2 95/20mm
• 08435288480329: 10TEMP RATAVA DISC 10 LAYERS COLOR C4 95/20mm
• 08435288480312: 10TEMP RATAVA DISC 10 LAYERS COLOR C3 95/20mm
• 08435288480305: 10TEMP RATAVA DISC 10 LAYERS COLOR C2 95/20mm
• 08435288480299: 10TEMP RATAVA DISC 10 LAYERS COLOR C1 95/20mm
• 08435288480282: 10TEMP RATAVA DISC 10 LAYERS COLOR B4 95/20mm
• 08435288480275: 10TEMP RATAVA DISC 10 LAYERS COLOR B3 95/20mm
• 08435288480268: 10TEMP RATAVA DISC 10 LAYERS COLOR B2 95/20mm
• 08435288480251: 10TEMP RATAVA DISC 10 LAYERS COLOR B1 95/20mm
• 08435288480244: 10TEMP RATAVA DISC 10 LAYERS COLOR A4 95/20mm
• 08435288480237: 10TEMP RATAVA DISC 10 LAYERS COLOR A3,5 95/20mm
• 08435288480220: 10TEMP RATAVA DISC 10 LAYERS COLOR A3 95/20mm
• 08435288480213: 10TEMP RATAVA DISC 10 LAYERS COLOR A2 95/20mm
• 08435288480206: 10TEMP RATAVA DISC 10 LAYERS COLOR A1 95/20mm
• 08435288480190: 10TEMP RATAVA DISC 10 LAYERS COLOR BL4 98,5/20mm
• 08435288480183: 10TEMP RATAVA DISC 10 LAYERS COLOR BL3 98,5/20mm
• 08435288480176: 10TEMP RATAVA DISC 10 LAYERS COLOR BL2 98,5/20mm
• 08435288480169: 10TEMP RATAVA DISC 10 LAYERS COLOR BL1 98,5/20mm
• 08435288480152: 10TEMP RATAVA DISC 10 LAYERS COLOR D4 98,5/20mm
• 08435288480145: 10TEMP RATAVA DISC 10 LAYERS COLOR D3 98,5/20mm
• 08435288480138: 10TEMP RATAVA DISC 10 LAYERS COLOR D2 98,5/20mm