Spherodon - M Econom 120112

GUDID 07290012207495

Dental Amalgam

SILMET LTD

Dental amalgam

• Primary Device ID: 07290012207495
• NIH Device Record Key: d80f2dc5-3fcc-48bb-9e1d-9b83ee4cd291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spherodon - M Econom
• Version Model Number: 120112
• Catalog Number: 120112
• Company DUNS: 600071344
• Company Name: SILMET LTD
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290012207495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760980

FDA Product Code

• EJJ: Alloy, Amalgam

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: 2018-12-28
• Device Publish Date: 2016-10-26

Devices Manufactured by SILMET LTD

• 07290012207914 - ProFil Flow: 2019-01-08 Dental Composite Restorative
• 07290012207006 - Nogama: 2018-12-28 Dental Amalgam Capsules
• 07290012207013 - Nogama: 2018-12-28 Dental Amalgam Capsules
• 07290012207044 - Nogama: 2018-12-28 Dental Amalgam Capsules
• 07290012207051 - Nogama: 2018-12-28 Dental Amalgam Capsules
• 07290012207068 - Nogama: 2018-12-28 Dental Amalgam capsules
• 07290012207075 - Nogama: 2018-12-28 Dental Amalgam Capsules
• 07290012207112 - Nogama: 2018-12-28 Dental Amalgam Capsules