Spherodon - M O-120493

GUDID 07290012207389

Dental Amalgam Capsules

SILMET LTD

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam

• Primary Device ID: 07290012207389
• NIH Device Record Key: 8489b5b5-27a1-4036-b4eb-82861fdb554a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spherodon - M
• Version Model Number: O-120493
• Catalog Number: O-120493
• 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	07290012207389 [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

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