EDS Core Forms 890-00

GUDID 00766054001294

48 Clear Core Forms

ESSENTIAL DENTAL SYSTEMS, INC.

Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould Dental mould

• Primary Device ID: 00766054001294
• NIH Device Record Key: d35ee18d-475f-42dd-9d83-92fdecfe7db8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDS Core Forms
• Version Model Number: 890-00
• Catalog Number: 890-00
• 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: false
• 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	00766054001294 [Primary]

FDA Product Code

• EIY: INSTRUMENT, FILLING, PLASTIC, DENTAL

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

Devices Manufactured by ESSENTIAL DENTAL SYSTEMS, INC.

• 00766054002901 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002918 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002925 - Bio-LCB: 2022-11-07 50 Light Cured Base and Liner Syringe Tips
• 00766054002932 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054000617 - Tango-Endo: 2020-07-27 Tango-Endo Intro Kit 25mm
• 00766054000624 - Tango-Endo: 2020-07-27 Tango-Endo Intro Kit 21mm
• 00766054000631 - Tango-Endo: 2020-07-27 Tango-Endo Refill Shaping 21mm
• 00766054000648 - Tango-Endo: 2020-07-27 Tango-Endo Refill Shaping 25 mm