FDA Registration
Active
🇺🇸 United States
G & H Wire Company
Reg #: 1833132
·
FEI: 1833132
·
Expires 2026
Products
21
Proprietary Names
127
Establishment Types
5
Classifications
21
Registration Details
- Registration Name
- G & H Wire Company
- Registration Number
- 1833132
- FEI Number
- 1833132
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 40 Linville Way
- City
- Franklin
- State
- IN
- ZIP
- 46131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132368
Owner / Operator
- Firm Name
- G&H Wire Company
- Operator Number
- 1833132
- Address
- 40 Linville Way
- City
- Franklin
- State
- IN
- Postal Code
- 46131
- Country
- US
- Correspondent
- SaPrina Bemis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 1992-11-22 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2013-12-27 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2004-08-20 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2004-08-20 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2004-09-13 |
| Headgear, Extraoral, Orthodontic | DZB | Class 2 | Dental | No | 2008-01-09 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2026-06-11 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2004-08-20 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1992-11-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2020-12-27 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2004-08-20 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2004-09-13 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2008-10-13 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2014-03-10 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2001-07-17 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2005-12-28 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2001-07-17 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2005-12-28 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2009-05-20 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2023-09-08 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2004-11-05 |
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
Auralis
miniPrevail®
CANNON ULTRA
KLO
VIPER
MAGNUM
VIPER CV
A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE
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
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
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
PROFLEX
G4 TAD
G4 ORTHO FORCE
G4
NEET
SureGrip
Mini-Mold
Therma-stick
EXCELSIOR
PARAGON
ARMADA
Zand
OrthoExact
NEOsmile
Ultraesthetic
GRIPPER
TURBO
TURBO XTRA
AGILITY TWIN
WILDSMILES
FOCUS
CANNON ELITE
COMFORT ZONE
Algi-Mate
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility