ZIRento

GUDID D862Z16B21598ST0

ZIRento 16 B2 15mm 98mm Step

DISTRIBUDENT, LLC

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: D862Z16B21598ST0
• NIH Device Record Key: 664bcb96-04e8-48e2-91a1-53f5eb0c9ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIRento
• Version Model Number: Z16B2-1598ST
• Company DUNS: 080458846
• Company Name: DISTRIBUDENT, LLC
• 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: true
• 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 Dimensions

• Height: 15 Millimeter
• Height: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D862Z16B21598ST0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130924

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-12-07

On-Brand Devices [ZIRento]

• D862ZW2598STSI0: ZIRento White 25mm 98mm Step - SI
• D862ZW2598ST0: ZIRento White 25mm 98mm Step
• D862ZW2098STSI0: ZIRento White 20mm 98mm Step - SI
• D862ZW2098ST0: ZIRento White 20mm 98mm Step
• D862ZW1598STSI0: ZIRento White 15mm 98mm Step -SI
• D862ZW1598ST0: ZIRento White 15mm 98mm Step
• D862ZW1298STSI0: ZIRento White 12mm 98mm Step - SI
• D862ZW1298ST0: ZIRento White 12mm 98mm Step
• D862Z16D42598STSI0: ZIRento 16 D4 25mm 98mm Step - SI
• D862Z16D42598ST0: ZIRento 16 D4 25mm 98mm Step
• D862Z16D42098STSI0: ZIRento 16 D4 20mm 98mm Step - SI
• D862Z16D42098ST0: ZIRento 16 D4 20mm 98mm Step
• D862Z16D41598STSI0: ZIRento 16 D4 15mm 98mm Step - SI
• D862Z16D41598ST0: ZIRento 16 D4 15mm 98mm Step
• D862Z16D41298STSI0: ZIRento 16 D4 12mm 98mm Step - SI
• D862Z16D41298ST0: ZIRento 16 D4 12mm 98mm Step
• D862Z16D32598STSI0: ZIRento 16 D3 25mm 98mm Step - SI
• D862Z16D32598ST0: ZIRento 16 D3 25mm 98mm Step
• D862Z16D32098STSI0: ZIRento 16 D3 20mm 98mm Step - SI
• D862Z16D32098ST0: ZIRento 16 D3 20mm 98mm Step
• D862Z16D31598STSI0: ZIRento 16 D3 15mm 98mm Step - SI
• D862Z16D31598ST0: ZIRento 16 D3 15mm 98mm Step
• D862Z16D31298STSI0: ZIRento 16 D3 12mm 98mm Step - SI
• D862Z16D31298ST0: ZIRento 16 D3 12mm 98mm Step
• D862Z16D22598STSI0: ZIRento 16 D2 25mm 98mm Step - SI
• D862Z16D22598ST0: ZIRento 16 D2 25mm 98mm Step
• D862Z16D22098STSI0: ZIRento 16 D2 20mm 98mm Step - SI
• D862Z16D22098ST0: ZIRento 16 D2 20mm 98mm Step
• D862Z16D21598STSI0: ZIRento 16 D2 15mm 98mm Step - SI
• D862Z16D21598ST0: ZIRento 16 D2 15mm 98mm Step
• D862Z16D21298STSI0: ZIRento 16 D2 12mm 98mm Step - SI
• D862Z16D21298ST0: ZIRento 16 D2 12mm 98mm Step
• D862Z16C42598STSI0: ZIRento 16 C4 25mm 98mm Step - SI
• D862Z16C42598ST0: ZIRento 16 C4 25mm 98mm Step
• D862Z16C42098STSI0: ZIRento 16 C4 20mm 98mm Step - SI
• D862Z16C42098ST0: ZIRento 16 C4 20mm 98mm Step
• D862Z16C41598STSI0: ZIRento 16 C4 15mm 98mm Step - SI
• D862Z16C41598ST0: ZIRento 16 C4 15mm 98mm Step
• D862Z16C41298STSI0: ZIRento 16 C4 12mm 98mm Step - SI
• D862Z16C41298ST0: ZIRento 16 C4 12mm 98mm Step
• D862Z16C32598STSI0: ZIRento 16 C3 25mm 98mm Step - SI
• D862Z16C32598ST0: ZIRento 16 C3 25mm 98mm Step
• D862Z16C32098STSI0: ZIRento 16 C3 20mm 98mm Step - SI
• D862Z16C32098ST0: ZIRento 16 C3 20mm 98mm Step
• D862Z16C31598STSI0: ZIRento 16 C3 15mm 98mm Step - SI
• D862Z16C31598ST0: ZIRento 16 C3 15mm 98mm Step
• D862Z16C31298STSI0: ZIRento 16 C3 12mm 98mm Step - SI
• D862Z16C31298ST0: ZIRento 16 C3 12mm 98mm Step
• D862Z16C22598STSI0: ZIRento 16 C2 25mm 98mm Step - SI
• D862Z16C22598ST0: ZIRento 16 C2 25mm 98mm Step