PERMITE 4002202

GUDID 09336472000387

PERMITE 2SP FAST 50

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: 09336472000387
• NIH Device Record Key: 06dfe2cf-b23c-4057-a222-5e7e7ac13db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERMITE
• Version Model Number: 4002202
• Catalog Number: 4002202
• 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	09336472000387 [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: 2025-01-16
• Device Publish Date: 2025-01-08

On-Brand Devices [PERMITE]

• DO3640603032: PERMITE ALLOY REG 5OZ
• DO3640602022: PERMITE ALLOY FAST 5OZ
• DO3640503032: PERMITE TABS REG 5OZ
• DO3640502022: PERMITE TABS FAST 5OZ
• DO3640250002: PERMITE 5SP 500
• DO3640234042: PERMITE 3SP SLOW 500
• DO3640233032: PERMITE 3SP REG 500
• DO3640232022: PERMITE 3SP FAST 500
• DO3640231012: PERMITE 3SP ECT 500
• DO3640224642: PERMITE 2SP SC 500
• DO3640224042: PERMITE 2SP SLOW 500
• DO3640223032: PERMITE 2SP REG 500
• DO3640222022: PERMITE 2SP FAST 500
• DO3640221012: PERMITE 2SP ECT 500
• DO3640214042: PERMITE 1SP SLOW 500
• DO3640213032: PERMITE 1SP REG 500
• DO3640212022: PERMITE 1SP FAST 500
• DO3640211012: PERMITE 1SP ECT 500
• DO3640050002: PERMITE 5SP REG 50
• DO3640034642: PERMITE 3SP SC 50
• DO3640034042: PERMITE 3SP SLOW 50
• DO3640033032: PERMITE 3SP REG 50
• DO3640032022: PERMITE 3SP FAST 50
• DO3640031012: PERMITE 3SP ECT 50
• DO3640024642: PERMITE 2SP SC 50
• DO3640024042: PERMITE 2SP SLOW 50
• DO3640023032: PERMITE 2SP REG 50
• DO3640022022: PERMITE 2SP FAST 50
• DO3640021012: PERMITE 2SP ECT 50
• DO3640014042: PERMITE 1SP SLOW 50
• DO3640013032: PERMITE 1SP REG 50
• DO3640012022: PERMITE 1SP FAST 50
• DO3640011012: PERMITE 1SP ECT 50
• 09336472001247: PERMITE 5SP 500
• 09336472001216: PERMITE 3SP SLOW 500
• 09336472001186: PERMITE 3SP REG 500
• 09336472001155: PERMITE 3SP FAST 500
• 09336472001087: PERMITE 2SP SLOW 500
• 09336472001056: PERMITE 2SP REG 500
• 09336472001025: PERMITE 2SP FAST 500
• 09336472000998: PERMITE 2SP ECT 500
• 09336472000936: PERMITE 1SP REG 500
• 09336472000905: PERMITE 1SP FAST 500
• 09336472000875: PERMITE 1SP ECT 500
• 09336472000639: PERMITE 5SP REG 50
• 09336472000592: PERMITE 3SP SLOW 50
• 09336472000561: PERMITE 3SP REG 50
• 09336472000530: PERMITE 3SP FAST 50
• 09336472000462: PERMITE 2SP SLOW 50
• 09336472000424: PERMITE 2SP REG 50