Dentoclude F

Basic Information

• Brand Name: Dentoclude F
• Primary DI: G402DENTOCLUDE1
• Version / Model: 1
• Catalog Number: Dentoclude1
• Company Name: CUMBERLAND BIOTHERAPEUTICS LLC
• Labeler DUNS: 124005284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-19
• Public Version: 1
• Public Version Date: 2026-03-27
• Public Version Status: New
• Public Device Record Key: 5c1eb004-1a9c-4262-8d00-1bfe3f86d837
• Distribution End Date: 2026-08-04

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBH	Varnish, Cavity	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G402DENTOCLUDE1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K082071	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 35 – 80 Degrees Fahrenheit