Data / Medical devices / Prosthesis, Breast, External, Used With Adhesive
Prosthesis, Breast, External, Used With Adhesive (KCZ): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Prosthesis, Breast, External, Used With Adhesive (product code KCZ, Class 1, 21 CFR 878.3800). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on April 16, 1999, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCZ
- Device class
- 1
- Regulation
- 878.3800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| Switzerland | 2 |
| China | 2 |
| United States | 2 |
| Japan | 1 |
| Israel | 1 |
Makers of Prosthesis, Breast, External, Used With Adhesive
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 |
|---|---|---|---|---|---|---|---|---|
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 1 | April 16, 1999 | 0 | 0 | 0 | api.fda.gov |
| Straumann Villeret SA | VILLERET Bern, Switzerland | Manufacturer | 1 | April 16, 1999 | 0 | 0 | 0 | api.fda.gov |
| Allmay Bodywear (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Breast Care LP | Marietta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amoena Medizin-Orthopadie-Technik GMBH | Raubling, Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anita DR. Helbig GMBH | BRANNENBURG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delta Molding LLC | Woodland, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanning Sixtant Biotechnology Co., Ltd | Nanning Guangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natural Breast Co., Ltd. | Fukuoka-City, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pink Perfect | Kfar Saba Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steco-System-Technik GMBH & Co. KG | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne Deutschland GMBH | Burgwedel Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 16, 1999. 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.