remanium®

GUDID J011102620500

remanium® star Intro-Set

DENTAURUM GmbH & Co.KG

Dental casting non-noble alloy

• Primary Device ID: J011102620500
• NIH Device Record Key: 869ef936-74c1-471b-be58-362036e8d6a6
• Commercial Distribution Discontinuation: 2019-04-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: remanium®
• Version Model Number: 102-620-50
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	J011102620500 [Primary]

FDA Product Code

• EJH: ALLOY, METAL, BASE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-25
• Device Publish Date: 2016-09-15

On-Brand Devices [remanium®]

• J011102620500: remanium® star Intro-Set
• J011102200500: remanium GM 800+ Intro-Set
• J011102641000: remanium® LFC CoCr bonding alloy with a high CTE value / For further information please visit o
• J011100121000: remanium® LFC allergy plates
• J011728505000: remanium® lingual retainer, Length 30 mm
• J011728504000: remanium® lingual retainer, Length 28 mm
• J011728503000: remanium® lingual retainer, Length 26 mm
• J011728502000: remanium® lingual retainer, Length 24 mm
• J011728501000: remanium® lingual retainer, Length 22 mm
• J011728500000: remanium® lingual retainer assortment / For further information please visit our online-shop on
• J011100500000: remanium® Standard Casting Alloy
• J011102654000: remanium® star MD I milling blank, 10 mm border, Thickness 15 mm
• J011102653000: remanium® star MD I milling blank, 10 mm border, Thickness 13.5 mm
• J011102652000: remanium® star MD I milling blank, 10 mm border, Thickness 12 mm
• 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
• J011620708000: remanium® arrow clasps, ø 0.80 mm
• J011765113000: Standard-Arches Lower 0,40mm