# FDA 483 - Sirona Dental Systems GmbH - January 19, 2022

Source: https://www.keypedia.com/records/483/sirona-dental-systems-gmbh/ce55ac4e-d65e-4524-b47f-9cfff7c7ad20

> FDA 483 for Sirona Dental Systems GmbH on January 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sirona Dental Systems GmbH
- Inspection Date: 2022-01-19
- Product Type: device
- Office Name: FDA District Office — Edgewood, New York
- Summary: This document is a 510(k) summary (K210259) submitted by Parkell, Inc. for their Self-Adhesive Cement, a dental device. The submission details the device's description as a two-component, dual-cured, self-etching, self-adhesive resin cement intended for luting indirect restorations. It also identifies the primary predicate device as Dentsply International's Self-adhesive Cement (K073173).

## Related Officers

- [La-Shaunda Joseph](https://www.keypedia.com/people/la-shaunda-joseph/67cd5f8d-b726-4e9f-9885-cc19c1d5479c)

Company: https://www.keypedia.com/companies/sirona-dental-systems-gmbh/d3653077-804a-498b-98a1-40509b603347

Office: https://www.keypedia.com/offices/fda-district-office-edgewood-new-york/d5c3d6e6-5a9a-4f38-8b7a-bbdedb3df131