Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038253546

FEI Number

3038253546

Entity Name

ZND ENTERPRISES LLC

City/State/Country

Boynton Beach, FL, US

Establishment Address

8160 Pinnacle Pass Way, Boynton Beach, FL 33473, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ZND Enterprises LLC (Owner Number: 10092610)

Owner / Operator Contact Address

8160 Pinnacle Pass Way, Boynton Beach, FL 33473, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Babsy Build-A-Brush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-07-10

Official Correspondent

Dante Paolino

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZND Enterprises 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038253546. Last updated year: 2026. Please use registration number 3038253546 when referencing this establishment in official correspondence.