Prosthetic devices · 21 CFR 872 Subpart D
Mercury and/or Alloy Dispenser
FDA device type “Dispenser, Mercury And/Or Alloy”.
- Companies listing it
- 41 makers
- Brands and models
- 4
- 510(k) clearances
- 20 in five years
- FDA name
- Dispenser, Mercury And/Or Alloy
510(k) clearances per year, 1976–2026
Companies that list EHE
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Radiation Products Design, Inc | United States | Maker | Digital Alloy Dispenser · LOW AND HIGH ALLOY | — | — |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Compule Gun | 27 | 2024 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 28 Sep 1977 | K771749 | AMALGAM DISPENSER | New Dimensions IN Medicine, Inc. |
| 3 Aug 1977 | K771396 | DISPENSER, MERCURY & TABLET/POWDER | Johnson & Johnson Professionals, Inc. |
Official records: FDA product classification for EHE · 21 CFR 872.3080.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026