Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1833132

FEI Number

1833132

Entity Name

G & H Wire Company

City/State/Country

Franklin, IN, US

Establishment Address

40 Linville Way, Franklin, IN 46131, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

G&H Wire Company (Owner Number: 1833132)

Owner / Operator Contact Address

40 Linville Way, Franklin, IN 46131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BAMBINO-TIES EXTREME SPORTS Six Month Smiles® S-TIE VERSA-TIES DESIGNERTIES® SELECT-TIES DYNA-LINK ENCHANTED SERIES RAINBOW MINI-TIES PowerLinx GALACTIC FASTBRACES AGILITY VAPOR MBT CERAMIC BRACKETS VAPOR SYNC VAPOR ROTH CERAMIC BRACKETS Plastic Brackets (Pattern) TITAN SATURN Straight-Line N/A n/a N/A Auralis miniPrevail® CANNON ULTRA KLO AGILITY Straight-Line VIPER MAGNUM VIPER CV SYNC A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE KLO COLBOLOY TRUEFORM SOLO-PACK S3 TRUEFORM STAINLESS STEEL S3 TRUEFORM STAINLESS STEEL SOLO-PACK TRUEFORM POSTED Lucid-Lok G4 EUROPA NICKEL TITANIUM S3 ULTRAESTHETIC TRUEFORM STAINLESS STEEL A.J. Wilcock® G4 NICKEL TITANIUM SOLO-PACK COLBOLOY TRUEFORM ULTRAESTHETIC TRUEFORM S3 ULTRAESTHETIC STAINLESS STEEL SYNC TITANMOLY TRUEFORM TITANIUM MOLYBDENUM TitanMoly TITANMOLY T-LOOP G4 NICKEL TITANIUM G4 ULTRAESTHETIC EUROPA NICKEL TITANIUM S3 ULTRAESTHETIC TRUEFORM STAINLESS STEEL SOLO-PACK TRUEFORM TITANMOLY EUROPA TITANIUM MOLYBDENUM SOLO-PACK ULTRAESTHETIC TITANMOLY DYB TITANIUM MOLYBDENUM ULTRAESTHETIC TRUEFORM SOLO-PACK M5 THERMAL NICKEL TITANIUM SOLO-PACK G4orce NICKEL TITANIUM XR1 HEAT-TREATED STAINLESS STEEL G4 TRUEFORM NICKEL TITANIUM SOLO-PACK ULTRAESTHETIC EUROPA G4 TRUEFORM NICKEL TITANIUM M5 TRUEFORM THERMAL NICKEL TITANIUM SOLO-PACK TITANMOLY TITANIUM MOLYBDENUM G4 ULTRAESTHETIC NICKEL TITANIUM SOLO-PACK M5 TRUEFORM THERMAL NICKEL TITANIUM XR1 EUROPA HEAT-TREATED STAINLESS STEEL SOLO-PACK G4 EUROPA NICKEL TITANIUM SOLO-PACK G4 ULTRAESTHETIC TRUEFORM NICKEL TITANIUM EUROPA SOLO-PACK G4 ULTRAESTHETIC EUROPA NICKEL TITANIUM SOLO-PACK XR1 TRUEFORM HEAT-TREATED STAINLESS STEEL TRUEFORM KEYHOLE G4 DYB NICKEL TITANIUM ULTRAESTHETIC SOLO-PACK G4 ULTRAESTHETIC TRUEFORM NICKEL TITANIUM SOLO-PACK TITANMOLY TITANIUM MOLYBDENUM SOLO-PACK G4 ULTRAESTHETIC NICKEL TITANIUM S3 DYB STAINLESS STEEL S3 STAINLESS STEEL SOLO-PACK S3 EUROPA ULTRAESTHETIC STAINLESS STEEL SOLO-PACK XR1 HEAT-TREATED STAINLESS STEEL SOLO-PACK XR1 EUROPA HEAT-TREATED STAINLESS STEEL SOLO-PACK A.J. WILCOCK® AUSTRALIAN WIRE S3 EUROPA ULTRAESTHETIC STAINLESS STEEL S3 EUROPA STAINLESS STEEL SOLO-PACK M5 EUROPA THERMAL NICKEL TITANIUM M5 THERMAL NICKEL TITANIUM M5 FASTBRACES XR1 TRUEFORM HEAT-TREATED STAINLESS STEEL SOLO-PACK TRUEFORM SOLO-PACK EUROPA S3 EUROPA STAINLESS STEEL S3 ULTRAESTHETIC STAINLESS STEEL SOLO-PACK M5 EUROPA THERMAL NICKEL TITANIUM SOLO-PACK G4orce NICKEL TITANIUM SOLO-PACK COLBOLOY ULTRAESTHETIC EUROPA SOLO-PACK A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK S3 STAINLESS STEEL TITANMOLY TRUEFORM TITANIUM MOLYBDENUM SOLO-PACK TITANMOLY EUROPA TITANIUM MOLYBDENUM N/A PROFLEX G4 TAD G4 ORTHO FORCE G4 NEET n/a N/A SureGrip Mini-Mold Therma-stick EXCELSIOR PARAGON ARMADA Zand OrthoExact N/A n/a NEOsmile FASTBRACES N/A Ultraesthetic Lucid-Lok GRIPPER n/a Straight-Line TURBO miniPrevail® FASTBRACES TURBO XTRA SYNC AGILITY TWIN WILDSMILES AGILITY FOCUS CANNON ULTRA CANNON ELITE KLO COMFORT ZONE MAGNUM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	1992-11-22
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2013-12-27
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2004-08-20
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2004-08-20
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2004-09-13
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2008-01-09
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2026-06-11
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2004-08-20
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1992-11-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-12-27
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2004-08-20
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2004-09-13
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2011-10-17
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-10-13
EJL	Bur, Dental	Dental	Class 1	872.3240	2014-03-10
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2001-07-17
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2005-12-28
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-08-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2001-07-17
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2005-12-28
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2009-05-20
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2003-07-10

Official Correspondent

SaPrina Bemis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

G&H Wire Company

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

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 307850DISTRIBUTED 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 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 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-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

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3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US
3008882689	Xplora USA LLC	Carrollton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833132. Last updated year: 2026. Please use registration number 1833132 when referencing this establishment in official correspondence.