NexxZr™ S / A-71-16-NS-B4

GUDID 00842271102027

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

• Primary Device ID: 00842271102027
• NIH Device Record Key: 9e597a8b-3bcf-4cd7-8ce7-a5dcfa104471
• Commercial Distribution Discontinuation: 2018-04-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NexxZr™ S / A-71-16-NS-B4
• Version Model Number: A-42092
• 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	00842271102027 [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