FAIRFIELD ORTHODONTICS, LLC

FDA Device Registration & Listing · STRATFORD, CT, US · Registration 3006291983

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006291983
FEI Number
3006291983
Entity Name
FAIRFIELD ORTHODONTICS, LLC
City/State/Country
STRATFORD, CT, US
Establishment Address
410 SURF AVENUE, STRATFORD, CT 06615, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
FAIRFIELD ORTHODONTICS, LLC (Owner Number: 9101523)
Owner / Operator Contact Address
410 SURF AVENUE, --, Stratford, CT 06615, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

SMILES CERAMIC BRACKETS GEM PLUS BRACKETS STRATUS BRACKETS LP GEM BRACKETS ELASTICS ELASTOTIES ELASTOMERIC TIES FAIRFIELD BUCCAL TUBES ANCHOR BUCCAL TUBE PERFORMA INSTRUMENTS TITAN MOLAR BANDS FAIRFIELD BANDS BEST FIT MOLAR BANDS TIBEND WIRE SS WIRE NITI WIRE PERFORMA ADHEVISE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NJM Bracket, Ceramic, Orthodontic Dental Class 2 872.5470 2013-05-13
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2007-05-14
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2007-05-14
DZD Tube, Orthodontic Dental Class 1 872.5410 2007-05-14
JEX Plier, Orthodontic Dental Class 1 872.4565 2007-05-14
ECM Band, Preformed, Orthodontic Dental Class 1 872.5410 2007-05-14
DZC Wire, Orthodontic Dental Class 1 872.5410 2007-05-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2020-02-05

Official Correspondent

NICHOLAS LULKA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FAIRFIELD ORTHODONTICS, LLC
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
K180404 3M Healthcare 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 2018-03-16
K894358 Ormco Corp. LUMINA ORTHODONTIC BRACKET 1989-09-15
K925012 American Orthodontics PLASTIC CHAIN 1993-09-13
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2012 Biomet Microfixation, Inc. 1
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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1000118628 FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Denton, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006291983. Last updated year: 2026. Please use registration number 3006291983 when referencing this establishment in official correspondence.
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