Miscellaneous devices · 21 CFR 872 Subpart G
Composite Resin Warmer
Intended to warm composite materials prior to use
- Companies listing it
- 65 makers
- Brands and models
- 9
- 510(k) clearances
- 10 in five years
- FDA name
- Composite Resin Warmer
510(k) clearances per year, 1976–2026
Companies that list QGO
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Inter-Med, Inc. | United States | Maker | Phasor · Therma-Flo Composite Warmer · Therma-Flo Syringe Warmer · VisCalor | 7 | 2026 |
| Addent, Inc. | United States | Maker | Compex HD | 7 | 2019 |
| B&L Biotech Co., Ltd. | South Korea | Maker | WARMA PW-A2 · WARMO PW-A1 | 1 | 2006 |
| Solventum US LLC | United States | Maker | — | — | — |
| Bryant Medical Ltd | United Kingdom | Maker | C-Flo Multi-Material Heater | — | — |
| Voco GmbH | Germany | Foreign exporter | VisCalor Dispenser | 117 | 2026 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Apr 2019 | K182017 | Compex HD | Addent, Inc. |
Official records: FDA product classification for QGO · 21 CFR 872.6100.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026