Spherodon M Econom 120471

GUDID 07290016787764

Dental Amalgam Capsules

SILMET LTD

Dental amalgam

• Primary Device ID: 07290016787764
• NIH Device Record Key: bec59c28-e895-42ee-8e37-47eac98e01ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spherodon M Econom
• Version Model Number: 120471
• Catalog Number: 120471
• 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	07290016787764 [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: 2017-10-22

On-Brand Devices [Spherodon M Econom]

• 07290016787818: Dental Amalgam Capsules
• 07290016787801: Dental Amalgam Capsules
• 07290016787795: Dental Amalgam Capsules
• 07290016787788: Dental Amalgam Capsules
• 07290016787771: Dental Amalgam Capsules
• 07290016787764: Dental Amalgam Capsules