Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031570897

FEI Number

3031570897

Entity Name

HYPE ALIGN CLEAR ORTHODONTICS, LIMITADA

City/State/Country

Santa Ana San Jose, CR

Establishment Address

Snr 147 Radial Santa Ana, Calle Lindora 2a; Park, Bldg., Santa Ana San Jose 10903, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hype Align Clear Orthodontics, Limitada (Owner Number: 10090956)

Owner / Operator Contact Address

SNR 147 Radial Santa Ana Belen, Lindora Park, Building 2A, Santa Ana, CR-SJ 10903, CR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hype Align

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2024-06-06

Official Correspondent

Bernardo Vargas

US Agent Details

Randy Butler Business: Hype Align Clear Orthodontics Distribution, LLC Email: randy@health-exec.com Phone: (713) 4167749

Related Public Records

Same Entity

Hype Align Clear Orthodontics, Limitada

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 3031570897. Last updated year: 2026. Please use registration number 3031570897 when referencing this establishment in official correspondence.