Data / Medical devices / United States / G & H Wire Company
G & H Wire Company: FDA-registered device maker in Franklin, IN, United States, 5 510(k) clearances
G & H Wire Company is registered with the FDA (registration 1833132) in Franklin, IN, United States. It lists 21 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 4, 2023. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1833132
- Address
- 40 Linville Way, Franklin, IN, United States, 46131
- Owner or operator
- G&H Wire Company (1833132)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 22, 1992
- Registered through
- 2026
- Brand names listed
- A.J. WILCOCK® AUSTRALIAN WIRE, A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE, A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK, A.J. Wilcock®, AGILITY, AGILITY TWIN, ARMADA, Algi-Mate and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Headgear, Extraoral, Orthodontic | DZB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2023 | K222847 | Ceramic Brackets Orthometric | NJM | Substantially Equivalent | Orthometric - Industria E Comercio DE Produtos Medicos | accessdata.fda.gov |
| December 19, 2013 | K132368 | VAPOR CERAMIC BRACKET | NJM | Substantially Equivalent | Orthodontic Design and Production, Inc. | accessdata.fda.gov |
| October 3, 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 | DZB | Substantially Equivalent | Kwang Myung Daicom, Inc. | accessdata.fda.gov |
| July 10, 1996 | K961754 | SAFETY RELEASE MODULE | DZB | Substantially Equivalent | G & H Wire Co. | accessdata.fda.gov |
| July 30, 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 21, 2023 | 93810 | Class II | Ongoing | FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy | accessdata.fda.gov |
| January 21, 2021 | 87248 | Class II | Terminated | Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpos | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is to | accessdata.fda.gov |
| December 13, 2013 | 67378 | Class II | Terminated | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to a | Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark. | accessdata.fda.gov |
| July 12, 2011 | 59349 | Not yet classified | Terminated | Heat Activated Niti Arches, Natural, Upper,.019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth. | Heat Activated Niti, Natural, Upper,.019 x 25" Arch wires mixed with size 021x0.25" Arch Wires. | accessdata.fda.gov |
| January 7, 2008 | 59110 | Not yet classified | Terminated | Stainless Steel, Progressive Lower,.016: Arch Wires. Intended for use in orthodontic treatment | Boxes of stainless steel orthodontic wires were mislabeled as size.018" | accessdata.fda.gov |
Compare with other makers
- All makers of Bracket, Metal, Orthodontic
- All makers of Headgear, Extraoral, Orthodontic
- All makers of Tube, Orthodontic
- All makers of Instruments, Dental Hand
- All makers of Band, Elastic, Orthodontic
- All makers of Wire, Orthodontic
Updated February 2, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.