Manufacturer registered with FDA
MedCAD
Dallas, TX, United States. Lists 2 dental device types with FDA across 2 registered establishments, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 42020–2023
- Markets registered in
- 1United States
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What MedCAD currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | AccuPlan System 3DTi | 2021 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | AccuPlateAccuPlate 3DTi Patient-Specific Plating SystemAccuPlate Patient-Specific Plate | 2021 |
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 MedCAD as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Sep 2023 | K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | JEY Bone Plate |
| 7 Mar 2023 | K223024 | MedCAD AccuPlan System | DZJ Manual Wire Driver and Bone Drill |
| 12 Feb 2021 | K193280 | MedCAD® AccuPlate® Patient-Specific Plate | JEY Bone Plate |
| 29 Oct 2020 | K192282 | MedCAD® AccuPlan® System | DZJ Manual Wire Driver and Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MedCADFDA reg. 3021635140 | Plano, TX, United States | Manufacturer |
| VanDuzen, Inc. dba MedCADFDA reg. 3009196021 | Dallas, TX, United States | Manufacturer |
Other names on FDA records
VanDuzen, Inc. dba MedCAD
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037478). 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.