Contract manufacturerDOT AMERICA, INC. (Columbia City, IN)IndianaDentalOrthopedicClass IIClass III
DOT AMERICA, INC.
Contract manufacturer ยท Columbia City, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011461101 (openFDA record; or search FDA's registration database)
- FEI number
- 3011461101
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- DOT America, Inc. (FDA owner/operator no. 10048730)
- Registered address
- 335 Towerview Dr, Columbia City, IN 46725
- Contract listings
- 14 device listings, 14 product codes, first listed Feb 19, 2015
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | Contract manufacturing | Oct 21, 2015 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Apr 11, 2022 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | Orthopedic | Contract manufacturing | Apr 11, 2022 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 27, 2017 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 5, 2026 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Aug 5, 2026 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 5, 2026 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 5, 2026 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 14, 2025 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jun 6, 2019 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Aug 5, 2026 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Apr 11, 2022 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract manufacturing | Feb 19, 2015 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Apr 11, 2022 |