Prosthetic devices · 21 CFR 872 Subpart D
Amalgam Dental Capsule
FDA device type “Capsule, Dental, Amalgam”.
- Companies listing it
- 2012 makers
- Brands and models
- 33
- 510(k) clearances
- 40 in five years
- FDA name
- Capsule, Dental, Amalgam
510(k) clearances per year, 1976–2026
Companies that list DZS
20 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| GC America Inc. | United States | Maker | Capsule Applier III | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Self-Activating Capsules for Contour, Tytin, and Tytin FC · Tytin | 203 | 2026 |
| Sdi Limited | Australia | Maker | F400 · Lojic + · Ultracaps | 8 | 2022 |
| Worldwork S.R.L | Italy | Maker | CAPSULES, DENTAL AMALGAM | 1 | 2023 |
| Silmet , Ltd. | Israel | Maker | DEXITER DISPERSED AMALGAM · DEXITER SPHERICAL AMALGAM · NOGAMA · PROCOPPER · +3 | 3 | 2011 |
| Signor Seven International | Pakistan | Maker | Universal Capsule Dispensing Gun SKU 19-130 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental amalgam capsule | — | — |
| Medcave Private Limited | Pakistan | Maker | Dental Amalgam | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Trimed Pvt Ltd | Pakistan | Maker | Jensen Capsule Polisher 27 gauge · Kratz Capsule Polisher, Diamond Dusted · Kratz Capsule Polisher, Sandblasted · Simcoe Capsule Polisher Curved Sandblasted · +3 | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| J&J Instruments | United States | Maker | Julius Wirth | — | — |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | AMALGAMAX | 5 | 2022 |
| Jersey Dental Supplies | United States | Repacker / relabeler | Dispersalloy Capsules · TYTIN | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Spherical Alloy Capsule Sample | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Tytin Amalgam | — | — |
| Dental Brands for Less | Canada | Foreign exporter | KERR | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 14 Sep 1982 | K822610 | PRECAPSULED DENTAL AMALGAM | Syntex Dental Products, Inc. |
| 30 Dec 1980 | K802967 | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- | Johnson & Johnson Professionals, Inc. |
| 20 Sep 1978 | K781243 | MERCURY DISP. CAPSULE | Lee Pharmaceuticals |
| 21 Aug 1978 | K780966 | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals |
Official records: FDA product classification for DZS · 21 CFR 872.3110.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026