G & H Wire Company
Franklin, IN, US
G & H Wire Company appears in FDA device records in Franklin, IN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to G & H Wire Company carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Highland Metals510(k), enforcement report, recall
510(k) clearance history
FDA records hold 9 510(k) clearances for G & H Wire Company between 1993 and 2008. The busiest year on record is 1993, with 6. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 6 |
| 1994 | 1 |
| 1996 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081393 | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | OAT | Substantially Equivalent | |
| K961754 | SAFETY RELEASE MODULE | DZB | Substantially Equivalent | |
| K935638 | NITINOL, NITI | DZC | Substantially Equivalent | |
| K933374 | NITI COIL SPRINGS | DZC | Substantially Equivalent | |
| K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | DZC | Substantially Equivalent | |
| K933380 | REVERSE SURVE NITI ARCH WIRE | DZC | Substantially Equivalent | |
| K933379 | STAINLESS STEEL ARCHES | DZC | Substantially Equivalent | |
| K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | DZC | Substantially Equivalent | |
| K933376 | NITI ARCH WIRE ON A SPOOL | DZC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833132 | 1833132 | G & H Wire Company | 40 Linville Way, Franklin, IN 46131 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- ECQAligner, Bracket, Orthodontic
- ECIBand, Elastic, Orthodontic
- ECMBand, Preformed, Orthodontic
- NJMBracket, Ceramic, Orthodontic
- EJFBracket, Metal, Orthodontic
- EJLBur, Dental
- ECNClamp, Wire, Orthodontic
- EJBHandle, Instrument, Dental
- DZBHeadgear, Extraoral, Orthodontic
- OATImplant, Endosseous, Orthodontic
- DZNInstruments, Dental Hand
- EBHMaterial, Impression Tray, Resin
- EAXMirror, Mouth
- JEXPlier, Orthodontic
- KMYPositioner, Tooth, Preformed
- ECOSpring, Orthodontic
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
- DZDTube, Orthodontic
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0976-2024 | 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 | Class II | Open, Classified | |
| Z-1164-2021 | 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 purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone. | 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 too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort. | Class II | Terminated | |
| Z-0923-2014 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 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 alter their position. | 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. | Class II | Terminated | |
| Z-0922-2014 | 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 alter their position. | 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. | Class II | Terminated | |
| Z-2963-2011 | 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. | Terminated | ||
| Z-2730-2011 | Stainless Steel, Natural, Lower, .018": Arch Wires. Highland Metals, San Jose, CA 95125 | Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | Terminated | ||
| Z-2729-2011 | Stainless Steel, Natural, Upper, .018": Arch Wires. Highland Metals, San Jose, CA 95125 | Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | Terminated | ||
| Z-2728-2011 | Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. Highland Metals, San Jose, CA 95125 | Boxes of stainless steel orthodontic wires were mislabeled with the incorrect size. | Terminated | ||
| Z-2727-2011 | Stainless Steel, Progressive Lower, .016: Arch Wires. Intended for use in orthodontic treatment | Boxes of stainless steel orthodontic wires were mislabeled as size.018" | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain