Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025666291

FEI Number

3025666291

Entity Name

CUMBERLAND BIOTHERAPEUTICS, LLC.

City/State/Country

Sewanee, TN, US

Establishment Address

1565 Jackson Point Road, Sewanee, TN 37375, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Cumberland Biotherapeutics, LLC. (Owner Number: 10086906)

Owner / Operator Contact Address

1565 Jackson Point Road, Sewanee, TN 37375, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082071

PMA Number

N/A

All Registered Proprietary Names

DentoClude F

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2022-12-22

Official Correspondent

David Dancy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cumberland Biotherapeutics, LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025666291. Last updated year: 2026. Please use registration number 3025666291 when referencing this establishment in official correspondence.