Scican Ltd.
TORONTO Ontario, CA
SCICAN LTD. appears in FDA device records in TORONTO Ontario, CA. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Scican Ltd. between 1991 and 2022. The busiest year on record is 1997, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| 1999 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214057 | STATIM 6000B Vacuum Autoclave | FLE | Substantially Equivalent | |
| K210326 | Bravo G4 Chamber Autoclave | FLE | Substantially Equivalent | |
| K192910 | STATClave G4 Chamber Autoclave | FLE | Substantially Equivalent | |
| K190062 | STATCLAVE G4 Chamber Autoclave | FLE | Substantially Equivalent | |
| K172292 | SALUS - Hygiene Instrument Reprocessing Container | KCT | Substantially Equivalent | |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | EGS | Substantially Equivalent | |
| K112872 | STATIM 2000 G4 CASSETTE | FLE | Substantially Equivalent | |
| K090937 | E-STATIS 40 SYSTEM | EBW | Substantially Equivalent | |
| K090265 | BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V | FLE | Substantially Equivalent | |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | EFB | Substantially Equivalent | |
| K072466 | STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 | FLE | Substantially Equivalent | |
| K071891 | STATIS DENTAL HANDPIECES | EFB | Substantially Equivalent | |
| K062418 | K-SPRAY, MODEL 085-2715 | EFB | Substantially Equivalent | |
| K021064 | QUANTIM 16 AUTOCLAVE | FLE | Substantially Equivalent | |
| K983679 | STATIM 5000 CASSETTE AUTOCLAVE | FLE | Substantially Equivalent | |
| K964691 | TCB TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | |
| K962179 | STAT IM 5000 CASSETTE AUTOCLAVE | FLE | Substantially Equivalent | |
| K944036 | STERIMASTER AUTOCLAVE | FLE | Substantially Equivalent | |
| K945142 | POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) | ELW | Substantially Equivalent | |
| K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION | FLE | Substantially Equivalent | |
| K910241 | STATIM CASSETTE AUTOCLAVE | FLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043629 | 1000273801 | SCICAN LTD. | 1440 DON MILLS RD., TORONTO Ontario M3B 3P9 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JRGBlock, Heating
- FLGCleaner, Ultrasonic, Medical Instrument
- EBWController, Foot, Handpiece And Cord
- EBGCrown And Bridge, Temporary, Resin
- LDSDevice, Pasteurization, Hot Water
- MECDisinfector, Medical Devices
- EFBHandpiece, Air-Powered, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- ELWMaterial, Impression
- OUGMedical Device Data System
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FLESterilizer, Steam
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2286-2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303 | 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. | Class II | Open, Classified | |
| Z-2285-2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain