Straumann Extraoral Implant System
EO Profile drill for implant 042.367S Ø 2.8mm, L 25mm, stainless steel
2manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Nanning Sixtant Biotechnology Co., Ltd. | Nanning | Guangxi | Manufacturer | 13 |
Record
| Listed by | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | KCZ |
| Device type | Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2024-05-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight |
| Sizes | Length 3.5 to 25 mm; outer diameter 2.8 to 4.8 mm; angle 15 ° |
| Distribution end date | 2026-04-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EO | Length 24 mm | In distribution |
| EO | Length 22.5 mm | In distribution |
| EO | Length 25 mm | In distribution |
| EO | Length 25 mm | In distribution |
| EO | Length 5.5 mm | Withdrawn |
| EO | Length 10 mm | Withdrawn |
| EO | Length 3.5 mm | Withdrawn |
| EO | Outer Diameter 3.5 mm | Withdrawn |
| EO | Outer Diameter 3.3 mm | Withdrawn |
| EO | Length 3.5 mm | Withdrawn |
| EO | Angle 15 ° | Withdrawn |
| EO | Length 5.5 mm | Withdrawn |
| EO | Length 3.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amoena | Amoena Medizin-Orthopädie-Technik GmbH | 230 |
| StecoTitanmagnetics® | Steco-System-Technik Gmbh & Co. KG | 55 |
| my breast | Natural Breast K.K. | 37 |
| Massage Form® Attach | American Breast Care, L.P. | 12 |
| ABC Nipple | American Breast Care, L.P. | 9 |
| Massage Form® Shaper Attach | American Breast Care, L.P. | 9 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.