Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015595297

FEI Number

3015595297

Entity Name

NEW ENGLAND ORTHODONTIC LABORATORY

City/State/Country

Andover, MA, US

Establishment Address

3 Riverside Dr, Ste 1, Andover, MA 01810, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

New England Orthodontic Laboratory (Owner Number: 10074294)

Owner / Operator Contact Address

3 Riverside Dr, Andover, MA 01810, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203339

PMA Number

N/A

All Registered Proprietary Names

NEOLab Clear Aligners

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

New England Orthodontic Laboratory

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

View Entity Profile →

Similar Registrations

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3031606517	Envista (Sichuan) Medical Device Co., Ltd.	Ziyang Sichuan, CN
3009011037	MEM DENTAL TECHNOLOGY CO LTD	Tainan, TW
3017155477	uLab Systems, Inc	Memphis, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015595297. Last updated year: 2026. Please use registration number 3015595297 when referencing this establishment in official correspondence.