Spherodon - M 120150

GUDID 07290012207501

Dental Amalgam

SILMET LTD

Dental amalgam

• Primary Device ID: 07290012207501
• NIH Device Record Key: 82834334-402e-4410-8fe8-e79bdf0ba5f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spherodon - M
• Version Model Number: 120150
• Catalog Number: 120150
• 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	07290012207501 [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: 2018-12-03
• Device Publish Date: 2016-10-26

On-Brand Devices [Spherodon - M]

• 07290012207501: Dental Amalgam
• 07290012207488: Dental Amalgam
• 07290012207471: Dental Amalgam Capsules
• 07290012207464: Dental Amalgam Capsules
• 07290012207457: Dental Amalgam Capsules
• 07290012207440: Dental Amalgam Capsules
• 07290012207433: Dental Amalgam Capsules
• 07290012207426: Dental Amalgam Capsules
• 07290012207419: Dental Amalgam Capsules
• 07290012207402: Dental Amalgam Capsules
• 07290012207396: Dental Amalgam Capsules
• 07290012207389: Dental Amalgam Capsules
• 07290012207372: Dental Amalgam Capsules
• 07290012207365: Dental Amalgam Capsules
• 07290012207358: Dental Amalgam Capsules
• 07290012207341: Dental Amalgam Capsules
• 07290012207334: Dental Amalgam Capsules
• 07290012207327: Dental Amalgam Capsules
• 07290012207310: Dental Amalgam Capsules
• 07290012207303: Dental Amalgam Capsules
• 07290012207297: Dental Amalgam Capsules
• 07290012207280: Dental Amalgam Capsules
• 07290012207273: Dental Amalgam Capsules
• 07290012207266: Dental Amalgam Capsules
• 07290012207259: Dental Amalgam Capsules
• 07290012207242: Dental Amalgam Capsules