Data / Medical devices / Composite Resin Warmer
Composite Resin Warmer (QGO): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Composite Resin Warmer (product code QGO, Class 1, 21 CFR 872.6100). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 29, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QGO
- Device class
- 1
- Regulation
- 872.6100
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| South Korea | 1 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Composite Resin Warmer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Addent, Inc. | Danbury, CT, United States | Manufacturer | 1 | April 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bryant Dental | Chertsey Surrey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Germany GmbH | SEEFELD Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.