remanium®

GUDID J011765113000

Standard-Arches Lower 0,40mm

DENTAURUM GmbH & Co.KG

Orthodontic archwire

• Primary Device ID: J011765113000
• NIH Device Record Key: 960c5696-f9cb-4e6f-96a0-528f0ea5da75
• Commercial Distribution Discontinuation: 2024-06-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: remanium®
• Version Model Number: 765-113-00
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 100
• 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	J011765113000 [Primary]
HIBCC	J011765113001 [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: 2024-06-19
• Device Publish Date: 2016-09-15

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• J011728502000: remanium® lingual retainer, Length 24 mm
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• J011728500000: remanium® lingual retainer assortment / For further information please visit our online-shop on
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• J011102651000: remanium® star MD I milling blank, without border, Thickness 10 mm
• J011102650000: remanium® star MD I milling blank, without border, Thickness 8 mm
• J011102642000: remanium® LFC CoCr bonding alloy with a high CTE value / For further information please visit o
• J011102640000: remanium® LFC CoCr bonding alloy with a high CTE value/ For further information please visit ou
• J011102403000: remanium® CS+ NiCr bonding alloy with outstanding ceramic bond / For further information please
• J011102402000: remanium® CS+ NiCr bonding alloy with outstanding ceramic bond/ For further information please
• J011102401000: remanium® CS+ NiCr bonding alloy with outstanding ceramic bond / For further information please
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• J011765113000: Standard-Arches Lower 0,40mm