LOJIC + 4203404

GUDID 09336472001742

LOJIC+ 3SP SLOW 50

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: 09336472001742
• NIH Device Record Key: 51cbc525-9072-45ed-b7e4-bc06c0d9dae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOJIC +
• Version Model Number: 4203404
• Catalog Number: 4203404
• 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: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage conditions < 25°C (< 77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	09336472001742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801639

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: 2025-01-17
• Device Publish Date: 2025-01-09

Devices Manufactured by SDI LIMITED

• 09336472002091 - LOJIC+: 2025-01-23 LOJIC+ 2SP FAST 500
• 09336472018580 - Set PP: 2025-01-23 SET PP INTRA-ORAL TIPS (10)
• 09336472001452 - LOJIC+: 2025-01-17 LOJIC+ 1SP FAST 50
• 09336472001476 - LOJIC+: 2025-01-17 LOJIC+ 1SP REG 50
• 09336472001513 - LOJIC+: 2025-01-17 LOJIC+ 1SP SLOW 50
• 09336472001551 - LOJIC+: 2025-01-17 LOJIC+ 2SP FAST 50
• 09336472001599 - LOJIC+: 2025-01-17 LOJIC+ 2SP REG 50
• 09336472001643 - LOJIC+: 2025-01-17 LOJIC+ 2SP SLOW 50