BIOSEAL 1640-00

GUDID 00766054002949

Bioceramic Endodontic Sealer

ESSENTIAL DENTAL SYSTEMS, INC.

Hygroscopic dental cement

• Primary Device ID: 00766054002949
• NIH Device Record Key: 36b9f2bb-d542-44ce-8188-9976e175d68e
• Commercial Distribution Discontinuation: 2024-11-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOSEAL
• Version Model Number: 1640-00
• Catalog Number: 1640-00
• Company DUNS: 101147171
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• 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: false
• 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: +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
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 25 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054002949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202281

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

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: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [BIOSEAL]

• 00766054002970: EndoTips
• 00766054002949: Bioceramic Endodontic Sealer