Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006007013

FEI Number

3006007013

Entity Name

PARK-ISTRE, LLC.

City/State/Country

DALLAS, TX, US

Establishment Address

4001 McEwen Rd, STE. 408, DALLAS, TX 75244, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PARK-ISTRE, LLC. (Owner Number: 9093900)

Owner / Operator Contact Address

4001 McEwen Rd., STE. 408, Dallas, TX 75244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Acero 3S Crowns Acero Narrow NA Crowns Acero XT Crowns Acero NS Acero ES Crowns Acero ESL Crowns Acero Z1 Crowns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2006-10-25

Official Correspondent

CHAD PARK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PARK-ISTRE, LLC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006007013. Last updated year: 2026. Please use registration number 3006007013 when referencing this establishment in official correspondence.