Dentoclude F Dentoclude1

GUDID G402DENTOCLUDE1

Desensitizing agents for dentin surfaces by occluding dentin tubules to help prevent microleakage.

CUMBERLAND BIOTHERAPEUTICS LLC

Dental cavity varnish

• Primary Device ID: G402DENTOCLUDE1
• NIH Device Record Key: 5c1eb004-1a9c-4262-8d00-1bfe3f86d837
• Commercial Distribution Discontinuation: 2026-08-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentoclude F
• Version Model Number: 1
• Catalog Number: Dentoclude1
• Company DUNS: 124005284
• Company Name: CUMBERLAND BIOTHERAPEUTICS LLC
• 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: 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: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net
• Phone: 8008450279
• Email: solutions@dentocludef.net

Operating and Storage Conditions

• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G402DENTOCLUDE1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082071

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-27
• Device Publish Date: 2026-03-19