Miscellaneous devices · 21 CFR 872 Subpart G
Tube Impression and Matrix
FDA device type “Tube Impression And Matrix”.
- Companies listing it
- 2111 makers
- Brands and models
- 18
- 510(k) clearances
- 10 in five years
- FDA name
- Tube Impression And Matrix
510(k) clearances per year, 1976–2026
Companies that list KCQ
21 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Tube Impression And Matrix | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Impression mixing tips · intra-oral tips | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Mixing Tips, Intraoral Tips · Mixing Tubes | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| E Hahnenkratt GmbH | Germany | Maker | HAHNENKRATT-COPPER BANDS | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Mixing Tips | — | — |
| White Bite, Inc. | United States | Maker | Strip Crown | — | — |
| Huntar Company, Inc. | United States | Maker | George Gauge | — | — |
| Universal Plastics & Engineering Co. | United States | Maker | — | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | MATRIX KIT | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Mixing Tips | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Sectional Matrix Bands | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Tube Impression and Matrix | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tips | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Tube Impression | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Mar 1990 | K896621 | L.T.C. REPLACEMENT GASTROSTOMY TUBE | Intl. Medical Marketing, Inc. |
Official records: FDA product classification for KCQ · 21 CFR 872.6570.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026