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Sign in to claim this brandWhat Scican GmbH makes
Scican GmbH manufactures steam sterilizers, including chamber autoclaves and cassette-style models for medical and dental settings, as well as silicone-based dental impression materials in varying viscosities and set times. Their portfolio also includes surgical instrument maintenance products, such as lubricants and ultrasonic-cleaning water baths, alongside sterilization indicators for biological, chemical, and physical validation processes.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed under the 510(k) and UDI programs. These products are intended for use in the United States, where compliance with FDA requirements applies.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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Catalogue (128)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| STATIM 2000 Cassette Autoclave | 01-121101-R | FDA UDI | Class II | Unknown |
| HYDRIM C61W G4 Instrument Washer | C61W-D01-R | FDA UDI | Class II | Active |
| BRAVO 17 Autoclave | M7A300014 | FDA UDI | Class II | Unknown |
| BRAVO 21V Autoclave | M7A320014 | FDA UDI | Class II | Unknown |
| BRAVO 21V Autoclave | M7A320011 | FDA UDI | Class II | Unknown |
| STATIM 2000 G4 Cassette Autoclave | G4-121101 | FDA UDI | Class II | Active |
| HYDRIM L110W G4 Instrument Washer | L110W-D01-G4-R | FDA UDI | Class II | Unknown |
| Data Logger Statim/Hydrim | 01-111770 | FDA UDI | Class I | Active |
| STATIM 5000 G4 Cassette Autoclave | G4-201103 | FDA UDI | Class II | Active |
| BRAVO 17 Autoclave | W#AJM00B0000-L | FDA UDI | Class II | Unknown |
| STATIM 5000 Cassette Autoclave | 01-201104-L | FDA UDI | Class II | Active |
| Polysil Light Viscosity Fast Set | SH-101/F | FDA UDI | Class II | Active |
| BRAVO 17 Autoclave | M7A300011 | FDA UDI | Class II | Unknown |
| BRAVO 17V Autoclave | M7A310016-R | FDA UDI | Class II | Unknown |
| STATIM 7000 Cassette Autoclave | 01-702101-R | FDA UDI | Class II | Unknown |
| HYDRIM C61W G4 Instrument Washer | C61W-D01-L | FDA UDI | Class II | Active |
| HYDRIM C51W Instrument Washer | C51W-D01-R | FDA UDI | Class II | Unknown |
| STATIM 7000 Cassette Autoclave | 01-702100-R | FDA UDI | Class II | Active |
| Polysil Medium Viscosity Regular Set | SH-102 | FDA UDI | Class II | Active |
| Polysil Multipurpose Fast Set | SH-104/F | FDA UDI | Class II | Active |
| HYDRIM L110W Instrument Washer | L110W-D01-R | FDA UDI | Class II | Unknown |
| Tcb Temporary Crown And Bridge Material | K964691 | FDA 510(k) | Class II | Active |
| K-Spray, Model 085-2715 | K062418 | FDA 510(k) | Class I | Active |
| Statim Cassett Autoclave, Modification | K915054 | FDA 510(k) | Class II | Active |
| Quantim 16 Autoclave | K021064 | FDA 510(k) | Class II | Active |
| Sterimaster Autoclave | K944036 | FDA 510(k) | Class II | Active |
| Polysil (vinyl Polysiloxan Impression Material) | K945142 | FDA 510(k) | Class II | Active |
| Sanao 200l, Sanao 40 /sanao 40l, Sanao 10l, Sanao Psi / Sanao Pso, Sanao 40st | K132356 | FDA 510(k) | Class I | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Scican GmbH has two FDA recall records for the STATCLAVE G4, a dynamic air removal (prevacuum) tabletop steam sterilizer, both initiated on June 22, 2023. The records are marked with open and classified statuses, with reasons provided related to the device’s intended use for sterilizing medical products via pressurized steam.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 22, 2023 | Z-2285-2023 | — | open, classified | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. |
| Jun 22, 2023 | Z-2286-2023 | — | open, classified | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. |