System KN

GUDID EADT20050011

Nickel based dental casting bonding alloy, type 3

Adentatec GmbH Competence in Dental

Dental casting non-noble alloy

• Primary Device ID: EADT20050011
• NIH Device Record Key: 812c23c6-4cd2-4c52-b407-da5d597374d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System KN
• Version Model Number: 2005001
• Company DUNS: 537287336
• Company Name: Adentatec GmbH Competence in Dental
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EADT20050011 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-30

Devices Manufactured by Adentatec GmbH Competence in Dental

• EADT6008T1 - System Ti5-Blank 99,5 x 8 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 8 mm
• EADT6010T1 - System Ti5-Blank 99,5 x 10 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 10 mm
• EADT6012T1 - System Ti5-Blank 99,5 x 12 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 12 mm
• EADT6014T1 - System Ti5-Blank 99,5 x 14 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 14 mm
• EADT6015T1 - System Ti5-Blank 99,5 x 15 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 15 mm
• EADT6016T1 - System Ti5-Blank 99,5 x 16 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 16 mm
• EADT6018T1 - System Ti5-Blank 99,5 x 18 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 18 mm
• EADT6020T1 - System Ti5-Blank 99,5 x 20 mm: 2020-02-14 Non precious dental milling alloy on Ti6Al4V base, Grade 5, 99,5 x 20 mm