PERMITE 4025000

GUDID DO3640250002

SDI LIMITED

Dental amalgam alloy

• Primary Device ID: DO3640250002
• NIH Device Record Key: e672575a-5166-4cdb-a4d3-041c8e13f11f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERMITE
• Version Model Number: PERMITE 5SP 500
• Catalog Number: 4025000
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 500
• 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

Customer Support Contacts

• Phone: +18002285166
• Email: info@sdi.com.au

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3640250000 [Unit of Use]
HIBCC	DO3640250002 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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