Noninium®

GUDID J011768004000

Noninium® White ideal arches, round Maxillary, 0.45 mm / 18

DENTAURUM GmbH & Co.KG

Orthodontic archwire

• Primary Device ID: J011768004000
• NIH Device Record Key: f829340e-d839-4f5f-93f0-87cc53e72ed0
• Commercial Distribution Discontinuation: 2020-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Noninium®
• Version Model Number: 768-004-00
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 3
• 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: 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

Customer Support Contacts

• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011768004000 [Primary]
HIBCC	J011768004001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935140

FDA Product Code

• DZC: WIRE, ORTHODONTIC

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: 2020-01-13
• Device Publish Date: 2016-09-15

On-Brand Devices [Noninium®]

• J011764060000: Noninium® Arch Low., 0,41x0,41mm, Twisted
• J011520090000: Noninium® wire on coils, round, hard, ø 0.90 mm / 36
• J011764028000: Noninium® ideal arches, rectangular Maxillary, 0.48 x 0.64 mm / 19 x 25
• J011768004000: Noninium® White ideal arches, round Maxillary, 0.45 mm / 18
• J011764061000: Noninium® Arch Upp., 0,41x0,56mm, Twisted
• J011764058000: Noninium® Arch, Low., 0,50mm, Twisted
• J011764057000: Noninium® Arch, Upp., 0,50mm, Twisted
• J011764056000: Noninium® Arch, Low., 0,45mm, Twisted
• J011764055000: Noninium® Arch, Upp., 0,45mm, Twisted
• J011620209010: Noninium® ball retainer clasps, ø 0.90 mm/35
• J011520062000: Noninium® wire on coils, round, spring hard, ø 0.60 mm / 23
• J011764015000: Noninium® ideal arches, round Mandibular, 0.45 mm / 18
• J011764015100: Noninium® ideal arch, round mandibular, 0.45 mm / 18
• J011764013000: Noninium® ideal arches, round Mandibular, 0.40 mm / 16
• J011764023000: Noninium® ideal arches, rectangular Mandibular, 0.43 x 0.64 mm / 17 x 25
• J011764002000: Noninium® straight wires, round, spring hard plus, 0.40 mm / 16
• J011764000000: Noninium® straight wires, round, spring hard plus, 0.30 mm / 12
• J011764003100: Noninium® straight wire, Ø 0.45 mm/18
• J011764022000: Noninium® ideal arches, rectangular Maxillary, 0.43 x 0.64 mm / 17 x 25
• J011764012000: Noninium® ideal arches, round Maxillary, 0.40 mm / 16