Data / Medical devices / Warmer, Anesthetic Tube
Warmer, Anesthetic Tube (EFC): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Warmer, Anesthetic Tube (product code EFC, Class 1, 21 CFR 872.6100). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EFC
- Device class
- 1
- Regulation
- 872.6100
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| South Korea | 2 |
| Taiwan | 1 |
| Italy | 1 |
| Pakistan | 1 |
Makers of Warmer, Anesthetic Tube
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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medihub Co., Ltd. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical | Philadelphia, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rolence Ent. Inc. | CHUNGLI Taoyuan, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silfradent SRL | S.Sofia Forli, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.