BENCO SPHERICAL 5102363

GUDID 29336472004754

BENCO SPHR 2SP REG 50

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: 29336472004754
• NIH Device Record Key: e31e8669-3e06-4246-a70e-98c28e2512aa
• Commercial Distribution Discontinuation: 2026-02-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BENCO SPHERICAL
• Version Model Number: 5102363
• Catalog Number: 5102363
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	29336472004754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031658

FDA Product Code

• EJJ: Alloy, Amalgam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [BENCO SPHERICAL]

• 29336472004877: BENCO SPHR 2SP REG 500
• 29336472004754: BENCO SPHR 2SP REG 50