Manufacturer registered with FDA
G&H Wire Company
Franklin, IN, United States. Lists 20 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 153
- 510(k) clearances
- 21996–2008
- Markets registered in
- 142,195 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 14 markets
Where regulators' registries name G&H Wire Company as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | G&H Wire Company | 2 clearances | 1996–2008 | Below |
| Thailand | Thai FDA | Manufacturer | G&H WIRE COMPANY | 2,001 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | G&H Wire Company, Inc.G&H Wire Company · G & H Wire Company · +2 | 53 | 1998–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | G & H Wire CompanyG&H Wire Company · G&H WIRE COMPANY · +1 | 31 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | G and H Wire Company | 28 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | G&H WIRE COMPANYG & H WIRE COMPANY | 23 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | G&H Wire Company, Inc. | 18 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | G & H WIRE COMPANYG&H Wire Company, Inc. | 15 | 2005–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | G&H Wire Company Inc | 10 | 2018–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | G&H WIRE COMPANY | 9 | 2007–2015 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | G & H WIRE COMPANYG&H WIRE COMPANY | 3 | 2007–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | G&H® Wire Company | 2 | 2026–2026 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | G&H Wire Company, Inc. | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | G&H Wire Company, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What G&H Wire Company currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | AGILITYaneavFASTBRACESPlastic Brackets (Pattern)SYNCVAPORVAPOR MBT CERAMIC BRACKETSVAPOR ROTH CERAMIC BRACKETS | 2013 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | N/A | 2008 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | AGILITYAGILITY TWINAuralisCANNON ELITECANNON ULTRACOMFORT ZONEFASTBRACESFOCUSKLOMAGNUM 6 moreminiPrevail®Straight-LineSYNCTURBOTURBO XTRAWILDSMILES | 2003 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | A.J. Wilcock®A.J. WILCOCK® AUSTRALIAN WIREA.J. WILCOCK® TRUEFORM AUSTRALIAN WIREA.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACKCOLBOLOYCOLBOLOY TRUEFORMCOLBOLOY TRUEFORM SOLO-PACKEUROPAEUROPA SOLO-PACKFASTBRACES 64 moreG4 DYB NICKEL TITANIUMG4 EUROPA NICKEL TITANIUMG4 EUROPA NICKEL TITANIUM SOLO-PACKG4 NICKEL TITANIUMG4 NICKEL TITANIUM SOLO-PACKG4 TRUEFORM NICKEL TITANIUMG4 TRUEFORM NICKEL TITANIUM SOLO-PACKG4 ULTRAESTHETIC EUROPA NICKEL TITANIUMG4 ULTRAESTHETIC EUROPA NICKEL TITANIUM SOLO-PACKG4 ULTRAESTHETIC NICKEL TITANIUMG4 ULTRAESTHETIC NICKEL TITANIUM SOLO-PACKG4 ULTRAESTHETIC TRUEFORM NICKEL TITANIUMG4 ULTRAESTHETIC TRUEFORM NICKEL TITANIUM SOLO-PACKG4orce NICKEL TITANIUMG4orce NICKEL TITANIUM SOLO-PACKKLOLucid-LokM5M5 EUROPA THERMAL NICKEL TITANIUMM5 EUROPA THERMAL NICKEL TITANIUM SOLO-PACKM5 THERMAL NICKEL TITANIUMM5 THERMAL NICKEL TITANIUM SOLO-PACKM5 TRUEFORM THERMAL NICKEL TITANIUMM5 TRUEFORM THERMAL NICKEL TITANIUM SOLO-PACKS3 DYB STAINLESS STEELS3 EUROPA STAINLESS STEELS3 EUROPA STAINLESS STEEL SOLO-PACKS3 EUROPA ULTRAESTHETIC STAINLESS STEELS3 EUROPA ULTRAESTHETIC STAINLESS STEEL SOLO-PACKS3 STAINLESS STEELS3 STAINLESS STEEL SOLO-PACKS3 TRUEFORM STAINLESS STEELS3 TRUEFORM STAINLESS STEEL SOLO-PACKS3 ULTRAESTHETIC STAINLESS STEELS3 ULTRAESTHETIC STAINLESS STEEL SOLO-PACKS3 ULTRAESTHETIC TRUEFORM STAINLESS STEELS3 ULTRAESTHETIC TRUEFORM STAINLESS STEEL SOLO-PACKSOLO-PACKSYNCTitanMolyTITANMOLY DYB TITANIUM MOLYBDENUMTITANMOLY EUROPA TITANIUM MOLYBDENUMTITANMOLY EUROPA TITANIUM MOLYBDENUM SOLO-PACKTITANMOLY T-LOOPTITANMOLY TITANIUM MOLYBDENUMTITANMOLY TITANIUM MOLYBDENUM SOLO-PACKTITANMOLY TRUEFORM TITANIUM MOLYBDENUMTITANMOLY TRUEFORM TITANIUM MOLYBDENUM SOLO-PACKTRUEFORMTRUEFORM KEYHOLETRUEFORM POSTEDTRUEFORM SOLO-PACKULTRAESTHETICULTRAESTHETIC EUROPAULTRAESTHETIC EUROPA SOLO-PACKULTRAESTHETIC SOLO-PACKULTRAESTHETIC TRUEFORMULTRAESTHETIC TRUEFORM SOLO-PACKXR1 EUROPA HEAT-TREATED STAINLESS STEELXR1 EUROPA HEAT-TREATED STAINLESS STEEL SOLO-PACKXR1 HEAT-TREATED STAINLESS STEELXR1 HEAT-TREATED STAINLESS STEEL SOLO-PACKXR1 TRUEFORM HEAT-TREATED STAINLESS STEELXR1 TRUEFORM HEAT-TREATED STAINLESS STEEL SOLO-PACK | 1992 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | AGILITYCANNON ULTRAKLOMAGNUMminiPrevail®Straight-LineSYNCVIPERVIPER CV | 2004 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | ARMADAEXCELSIORMini-MoldOrthoExactPARAGONSureGripTherma-stickZand | 2008 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | n/a | 2004 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | Algi-Mate | 2023 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | BAMBINO-TIESDESIGNERTIES®DYNA-LINKENCHANTED SERIESEXTREME SPORTSFASTBRACESGALACTICMINI-TIESPowerLinxRAINBOW 4 moreS-TIESELECT-TIESSix Month Smiles®VERSA-TIES | 1992 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | SATURNStraight-LineTITAN | 2004 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | GRIPPERLucid-LokUltraesthetic | 2005 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | G4G4 ORTHO FORCEG4 TADNEETPROFLEX | 2004 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | n/a | 2001 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | N/A | 2004 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | N/A | 2001 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | n/a | 2004 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | n/a | 2009 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | N/A | 2014 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | ARMADAEXCELSIORPARAGON | 2004 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | NEOsmile | 2005 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names G&H Wire Company as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Aug 2008 | K081393 | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | OAT Orthodontic Endosseous Implant |
| 10 Jul 1996 | K961754 | SAFETY RELEASE MODULE | DZB Orthodontic Extraoral Headgear |
Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (1), Ortho Organizers, Inc. (1), Young Innovations Inc (1), Orthodontic Manufacturer SIA SRL (1).
Also lists devices cleared under other names
G&H Wire Company lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Orthometric - Industria E Comercio DE Produtos Medicos (1), Orthodontic Design and Production, Inc. (1), Kwang Myung Daicom, Inc. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 May 2023 | K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | NJM Orthodontic Ceramic Bracket |
| 19 Dec 2013 | K132368 | VAPOR CERAMIC BRACKET | Orthodontic Design and Production, Inc. | NJM Orthodontic Ceramic Bracket |
| 3 Oct 2011 | K111169 | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF | Kwang Myung Daicom, Inc. | DZB Orthodontic Extraoral Headgear |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corporation | EJF Orthodontic Metal Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| G & H Wire CompanyFDA reg. 1833132 | Franklin, IN, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1833132). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.