# Statis Dental Handpieces

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/statis-dental-handpieces-efb>
- Manufacturer: [Scican Ltd](https://devicerts.com/manufacturers/scican-ltd) (Canada)
- Name in the registry: STATIS DENTAL HANDPIECES
- Device class: Class I (US FDA)
- FDA product code: EFB

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K071891 · decision 2007-09-13 · decision SESE · status: Active

## Recalls

- Z-1208-2023 · Class II · ongoing · initiated 2023-01-20: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

## Identifiers

- 510(k) Number: K071891 [FDA 510(k)]
- FDA product code: EFB [FDA 510(k)]

## Classification

- Device class: Class I [FDA 510(k)]
- Regulation: 21 CFR Part 872.4200 [FDA 510(k)]
- Advisory committee: Dental [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Statis Dental Handpieces, Scican Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/statis-dental-handpieces-efb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/statis-dental-handpieces-efb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/statis-dental-handpieces-efb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.