Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029658587

FEI Number

3029658587

Entity Name

CLEFTALIGN INC.

City/State/Country

New York, NY, US

Establishment Address

333 East 30th St, Suite 15K, New York, NY 10016, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

cleftalign Inc. (Owner Number: 10088792)

Owner / Operator Contact Address

333 East 30th St, Suite 15K, New York, NY 10016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NoseAlign LipAlign

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2023-10-11

Official Correspondent

Pradip Shetye

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

cleftalign Inc.

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 3029658587. Last updated year: 2026. Please use registration number 3029658587 when referencing this establishment in official correspondence.