EDS Gutta Percha 5000-M

GUDID 00766054001300

EDS Gutta Percha Points - Medium

ESSENTIAL DENTAL SYSTEMS, INC.

Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point Root canal obturating point

• Primary Device ID: 00766054001300
• NIH Device Record Key: 5700e325-5059-4914-a4c7-067b15e4e940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDS Gutta Percha
• Version Model Number: 5000-M
• Catalog Number: 5000-M
• Company DUNS: 101147171
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054001300 [Primary]

FDA Product Code

• EKM: GUTTA-PERCHA

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: 2020-07-27
• Device Publish Date: 2020-07-17

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