Data / Medical devices / Tube Impression And Matrix
Tube Impression And Matrix (KCQ): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make Tube Impression And Matrix (product code KCQ, Class 1, 21 CFR 872.6570). 0 of them have 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 March 13, 1990, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCQ
- Device class
- 1
- Regulation
- 872.6570
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 5 |
| Germany | 1 |
| Pakistan | 1 |
| Brazil | 1 |
| Honduras | 1 |
Makers of Tube Impression And Matrix
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 |
|---|---|---|---|---|---|---|---|---|
| E. Hahnenkratt GMBH | KOENIGSBACH-STEIN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indusbello Industria De Instrumentos Odo | Londrina Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoguan Guanghua Plastic And Hardwear Products Ltd | Shaoguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecno Corona | Roatan Islas de la Bahia, Honduras | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Universal Plastics & Engineering Co. | Rockville, MD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| White Bite, Inc. | Parrish, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 13, 1990. 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.