Z-TEMP Z-4516/BL1

GUDID 08435288476643

Z-TEMP PMMA DISK MULTILAYER COLOR BL1 98,5/16mm

UNION DENTAL SA

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: 08435288476643
• NIH Device Record Key: 8cfc9015-001e-4f25-a595-127f248842e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-TEMP
• Version Model Number: DISK BL1 MULTI 98,5/16mm
• Catalog Number: Z-4516/BL1
• 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	08435288476643 [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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [Z-TEMP]

• 08435288476957: Z-TEMP PMMA DISK MULTILAYER COLOR D4 98,5/20mm
• 08435288476940: Z-TEMP PMMA DISK MULTILAYER COLOR D3 98,5/20mm
• 08435288476933: Z-TEMP PMMA DISK MULTILAYER COLOR D2 98,5/20mm
• 08435288476926: Z-TEMP PMMA DISK MULTILAYER COLOR C4 98,5/20mm
• 08435288476919: Z-TEMP PMMA DISK MULTILAYER COLOR C3 98,5/20mm
• 08435288476902: Z-TEMP PMMA DISK MULTILAYER COLOR C2 98,5/20mm
• 08435288476896: Z-TEMP PMMA DISK MULTILAYER COLOR C1 98,5/20mm
• 08435288476889: Z-TEMP PMMA DISK MULTILAYER COLOR BL4 98,5/20mm
• 08435288476872: Z-TEMP PMMA DISK MULTILAYER COLOR BL3 98,5/20mm
• 08435288476865: Z-TEMP PMMA DISK MULTILAYER COLOR BL2 98,5/20mm
• 08435288476858: Z-TEMP PMMA DISK MULTILAYER COLOR BL1 98,5/20mm
• 08435288476841: Z-TEMP PMMA DISK MULTILAYER COLOR B4 98,5/20mm
• 08435288476834: Z-TEMP PMMA DISK MULTILAYER COLOR B3 98,5/20mm
• 08435288476827: Z-TEMP PMMA DISK MULTILAYER COLOR B2 98,5/20mm
• 08435288476810: Z-TEMP PMMA DISK MULTILAYER COLOR B1 98,5/20mm
• 08435288476803: Z-TEMP PMMA DISK MULTILAYER COLOR B0 98,5/20mm
• 08435288476797: Z-TEMP PMMA DISK MULTILAYER COLOR A4 98,5/20mm
• 08435288476780: Z-TEMP PMMA DISK MULTILAYER COLOR A3,5 98,5/20mm
• 08435288476773: Z-TEMP PMMA DISK MULTILAYER COLOR A3 98,5/20mm
• 08435288476766: Z-TEMP PMMA DISK MULTILAYER COLOR A2 98,5/20mm
• 08435288476759: Z-TEMP PMMA DISK MULTILAYER COLOR A1 98,5/20mm
• 08435288476742: Z-TEMP PMMA DISK MULTILAYER COLOR D4 98,5/16mm
• 08435288476735: Z-TEMP PMMA DISK MULTILAYER COLOR D3 98,5/16mm
• 08435288476728: Z-TEMP PMMA DISK MULTILAYER COLOR D2 98,5/16mm
• 08435288476711: Z-TEMP PMMA DISK MULTILAYER COLOR C4 98,5/16mm
• 08435288476704: Z-TEMP PMMA DISK MULTILAYER COLOR C3 98,5/16mm
• 08435288476698: Z-TEMP PMMA DISK MULTILAYER COLOR C2 98,5/16mm
• 08435288476681: Z-TEMP PMMA DISK MULTILAYER COLOR C1 98,5/16mm
• 08435288476674: Z-TEMP PMMA DISK MULTILAYER COLOR BL4 98,5/16mm
• 08435288476667: Z-TEMP PMMA DISK MULTILAYER COLOR BL3 98,5/16mm
• 08435288476650: Z-TEMP PMMA DISK MULTILAYER COLOR BL2 98,5/16mm
• 08435288476643: Z-TEMP PMMA DISK MULTILAYER COLOR BL1 98,5/16mm
• 08435288476636: Z-TEMP PMMA DISK MULTILAYER COLOR B4 98,5/16mm
• 08435288476629: Z-TEMP PMMA DISK MULTILAYER COLOR B3 98,5/16mm
• 08435288476612: Z-TEMP PMMA DISK MULTILAYER COLOR B2 98,5/16mm
• 08435288476605: Z-TEMP PMMA DISK MULTILAYER COLOR B1 98,5/16mm
• 08435288476599: Z-TEMP PMMA DISK MULTILAYER COLOR B0 98,5/16mm
• 08435288476582: Z-TEMP PMMA DISK MULTILAYER COLOR A4 98,5/16mm
• 08435288476575: Z-TEMP PMMA DISK MULTILAYER COLOR A3,5 98,5/16mm
• 08435288476568: Z-TEMP PMMA DISK MULTILAYER COLOR A3 98,5/16mm
• 08435288476551: Z-TEMP PMMA DISK MULTILAYER COLOR A2 98,5/16mm
• 08435288476544: Z-TEMP PMMA DISK MULTILAYER COLOR A1 98,5/16mm