Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012771684

FEI Number

3012771684

Entity Name

ALLURE ORTHO

City/State/Country

Whitinsville, MA, US

Establishment Address

1 Main St, #10, Whitinsville, MA 01588, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ALLURE ORTHO (Owner Number: 10052651)

Owner / Operator Contact Address

1 Main St, # 10, Whitinsville, MA 01588, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2016-09-01
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-11-08
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2016-09-01
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2023-01-30
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2026-03-24
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2025-02-05

Official Correspondent

Jody Fitzsimmons

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALLURE ORTHO

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012771684. Last updated year: 2026. Please use registration number 3012771684 when referencing this establishment in official correspondence.