NexxZr™ S / W-98-16-NS-OM30-SD

GUDID 00814356028720

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#

SAGEMAX BIOCERAMICS, INC

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

• Primary Device ID: 00814356028720
• NIH Device Record Key: 96342bd3-5b8d-47e3-afe4-52e6432c2d2e
• Commercial Distribution Discontinuation: 2018-04-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NexxZr™ S / W-98-16-NS-OM30-SD
• Version Model Number: W-42202
• Company DUNS: 002265727
• Company Name: SAGEMAX BIOCERAMICS, INC
• 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: true
• 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	00814356028720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130991

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: 2
• Public Version Date: 2018-07-24
• Device Publish Date: 2018-03-26

Devices Manufactured by SAGEMAX BIOCERAMICS, INC

• 00842271158666 - NexxZr Plus Multi 2.0 B3 W98-20mm: 2024-03-28
• 00842271158673 - NexxZr Plus Multi 2.0 B4 W98-20mm: 2024-03-28
• 00842271158680 - NexxZr Plus Multi 2.0 C1 W98-20mm: 2024-03-28
• 00842271158697 - NexxZr Plus Multi 2.0 C2 W98-20mm: 2024-03-28
• 00842271158703 - NexxZr Plus Multi 2.0 C3 W98-20mm: 2024-03-28
• 00842271158710 - NexxZr Plus Multi 2.0 C4 W98-20mm: 2024-03-28
• 00842271158727 - NexxZr Plus Multi 2.0 D2 W98-20mm: 2024-03-28
• 00842271158734 - NexxZr Plus Multi 2.0 D3 W98-20mm: 2024-03-28