510(k) Report

FDA applicant

Scican, Ltd.

Toronto, CA21 decisions1991–20223 recalls

FDA records 21 decisions for Scican, Ltd. (Toronto, CA) from 1991 to 2022: 21 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and EFB (Handpiece, Air-Powered, Dental). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Scican”, “Scican GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Scican, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 22008: 12009: 22012: 12014: 12017: 12019: 12020: 12021: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2023

2023: 3
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Scican, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Scican, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FLESterilizer, Steam13decisions
  • EFBHandpiece, Air-Powered, Dental3decisions
  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental1decision
  • EBGCrown And Bridge, Temporary, Resin1decision
  • EBWController, Foot, Handpiece And Cord1decision
  • ELWMaterial, Impression1decision

Also: KCT (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 170 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132356Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STScican GmbH · 20143cite it
  • K073319Statmatic 31 Handpiece Maintenance UnitScican, Ltd. · 20082cite it
  • K915054Statim Cassett Autoclave, ModificationScican · 19922cite it
  • K072466Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101Scican, Ltd. · 20071cites it
  • K910241Statim Cassette AutoclaveScican · 19911cites it
  • K962179Stat IM 5000 Cassette AutoclaveScican · 19971cites it

What has FDA decided for it lately?

  • K214057STATIM 6000B Vacuum AutoclaveScican, Ltd. · 2022
  • K210326Bravo G4 Chamber AutoclaveScican, Ltd. · 2021
  • K192910STATClave G4 Chamber AutoclaveScican, Ltd. · 20201 recall
  • K190062STATCLAVE G4 Chamber AutoclaveScican, Ltd. · 20191 recall
  • K172292SALUS - Hygiene Instrument Reprocessing ContainerScican, Ltd. · 2017
  • K132356Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40STScican GmbH · 2014
  • K112872Statim 2000 G4 CassetteScican, Ltd. · 2012
  • K090937E-Statis 40 SystemScican, Ltd. · 2009

All 11 as Scican, Ltd. →All 9 as Scican →The one decision as Scican GmbH →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K190062STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health…Jun 22, 2023Class II
  • K192910STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health…Jun 22, 2023Class II
  • K071891SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material…Jan 20, 2023Class II