Noninium®

GUDID J011764015100

Noninium® ideal arch, round mandibular, 0.45 mm / 18

DENTAURUM GmbH & Co.KG

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire

• Primary Device ID: J011764015100
• NIH Device Record Key: e01c159c-2aef-4a76-9ac8-45e637d01181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Noninium®
• Version Model Number: 764-015-10
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 10
• 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
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• 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
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011764015100 [Primary]
HIBCC	J011764015101 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-30
• Device Publish Date: 2020-01-22

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