Manufacturer registered with FDA
Proto3000 Inc.
Vaughan, Canada. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What Proto3000 Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Vertex-Dental B.V. | 2023 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Direkt GmbHUpcera | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Vertex-Dental B.V. | 2023 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Dental Direkt GmbH | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Medit Scanner | 2023 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Exocad Exoplan | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Proto3000 Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dental Direkt GmbH (3), Vertex-Dental B.V. (3), exocad GmbH (1), Shenyang Upcera Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Jan 2023 | K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | NHA Endosseous Dental Implant Abutment |
| 21 Jul 2021 | K193352 | AbutmentCAD | exocad GmbH | PNP Dental Abutment Design Software for Dental Laboratory |
| 16 Apr 2020 | K193588 | DD Contrast | Dental Direkt GmbH | EIH Porcelain Powder |
| 1 Nov 2019 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 14 Feb 2019 | K183569 | DD cube ONE ML | Dental Direkt GmbH | EIH Porcelain Powder |
| 30 Jun 2017 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 1 Mar 2013 | K123220 | VERTEX THERMOSENS RIGID | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 28 Jan 2010 | K093560 | UPCERA ZIRCONIA BLANKS | Shenyang Upcera Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PROTO3000 INC.FDA reg. 3013343038 | Vaughan Ontario, Canada | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086557). 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.