Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015436889

FEI Number

3015436889

Entity Name

ZALINSKY ORTHO PARTS, LLC

City/State/Country

Charlotte, NC, US

Establishment Address

2207 Humberview Lane, Charlotte, NC 28270, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Zalinsky Ortho Parts, LLC (Owner Number: 10059915)

Owner / Operator Contact Address

2207 Humberview Lane, Charlotte, NC 28270, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isoglide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2019-03-08

Official Correspondent

Grant Coleman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zalinsky Ortho Parts, LLC

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009257060	Ortho Traction Pads	Norwalk, CT, US
2126683	AMERICAN ORTHODONTICS	SHEBOYGAN, WI, US
3014827340	MATRIX HEALTH, INC.	Greenville, SC, US
3015272949	Ormco Corporation	Brea, CA, US
8044058	FORESTADENT BERNHARD FORSTER GMBH	PFORZHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015436889. Last updated year: 2026. Please use registration number 3015436889 when referencing this establishment in official correspondence.