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Scican GmbH

Last updated May 24, 2026

What 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.

Information

Country: US
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Catalogue (128)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
STATIM 5000 Cassette Autoclave	01-201103-R	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320011-R	FDA UDI	Class II	Unknown
STATIM 5000 Cassette Autoclave	01-201103	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	W#AJG00B1000-L	FDA UDI	Class II	Unknown
Ensure Sterilization Pouch	SCI-SCP	FDA UDI	Class II	Unknown
BRAVO G4 Chamber Autoclave	7A620010	FDA UDI	Class II	Active
BRAVO 17 Autoclave	M7A300012	FDA UDI	Class II	Unknown
Ensure Type 5 Steam Sterilization Integrator	SCI-T5	FDA UDI	Class II	Active
Polysil Heavy Viscosity Regular Set	SH-103	FDA UDI	Class II	Active
Statcare spray	S500-6NA	FDA UDI	Class I	Active
HYDRIM L110W G4 Instrument Washer	L110W-D01SH-G4	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	W#AJG00D1000-R	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320012-L	FDA UDI	Class II	Unknown
BRAVO 17 Autoclave	W#AJM00B1000-R	FDA UDI	Class II	Unknown
Polysil Light Viscosity Regular Set	SH-101	FDA UDI	Class II	Active
Statmatic spray	STM500-6NA	FDA UDI	Class I	Active
Polysil Soft Putty Regular Set	SH-202	FDA UDI	Class II	Active
ENSURE Biological Indicators	SCI-BI100	FDA UDI	Class II	Active
Polysil Soft Putty Fast Set	SH-202/F	FDA UDI	Class II	Active
STATIM 5000 G4 Cassette Autoclave	G4-201103-R	FDA UDI	Class II	Active
Polysil Firm Putty Fast Set	SH-201/F	FDA UDI	Class II	Active
STATIM 2000 G4 Cassette Autoclave	G4-121101-R	FDA UDI	Class II	Active
SALUS-Hygiene	SALUS-10-AM	FDA UDI	Class II	Unknown
Sterilization Monitors, Steam	SCI134-US	FDA UDI	Class II	Active
STATCLAVE G4 Chamber Autoclave	G4-621103	FDA UDI	Class II	Active
Data Logger Bravo (G)	01-111729	FDA UDI	Class I	Active
BRAVO 17V Autoclave	M7A310011	FDA UDI	Class II	Unknown
HYDRIM C61WD G4 Instrument Washer-Disinfector	C61WD-D01-L	FDA UDI	Class II	Active
Polysil Rigid BR	SH-302	FDA UDI	Class II	Active
BRAVO 17V Autoclave	W#AJP00D1000-R	FDA UDI	Class II	Unknown
BRAVO 17 Autoclave	M7A300013	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320016	FDA UDI	Class II	Unknown
BRAVO 17V Autoclave	M7A310014-L	FDA UDI	Class II	Unknown
BRAVO 17V Autoclave	M7A310011-R	FDA UDI	Class II	Unknown
Bravo Thermal Printer Kit	95530085	FDA UDI	Class II	Unknown
BRAVO 17 Autoclave	W#AJM00D1000-R	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320013	FDA UDI	Class II	Unknown
STATIM 5000 Cassette Autoclave	01-201104-R	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320013-L	FDA UDI	Class II	Unknown
BRAVO G4 Chamber Autoclave	7A621030	FDA UDI	Class II	Active
HYDRIM L110W G4 Instrument Washer	L110W-D01-G4	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	W#AJG00B1000-R	FDA UDI	Class II	Unknown
BRAVO 21V Autoclave	M7A320012	FDA UDI	Class II	Unknown
StatClean Ultrasonic Cleaner	SC-P4862	FDA UDI	Class I	Active
BRAVO 17V Autoclave	M7A310016	FDA UDI	Class II	Unknown
STATCLAVE G4 Chamber Autoclave	G4-621103-L	FDA UDI	Class II	Active
STATCLAVE G4 Chamber Autoclave	G4-621103-R	FDA UDI	Class II	Active
BRAVO G4 Chamber Autoclave	7A620030	FDA UDI	Class II	Active
HYDRIM C61WD G4 Instrument Washer-Disinfector	C61WD-D01-R	FDA UDI	Class II	Active
HYDRIM L110W G4 Instrument Washer	L110W-D01-G4-L	FDA UDI	Class II	Unknown

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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.