# FDA 483 - Parkell, Inc. - January 29, 2020

Source: https://www.keypedia.com/records/483/parkell-inc/f0fdacb5-2a63-44a9-b6c9-000b1aaaff41

> FDA 483 for Parkell, Inc. on January 29, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Parkell, Inc.
- Inspection Date: 2020-01-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: This document is a Premarket Notification (Traditional 510(k)) submitted by Parkell, Inc. for their Self-Adhesive Cement, a Class II medical device. The submission, dated January 21, 2021, seeks clearance for a dual-component, dual-cured high-strength cement intended for various indirect dental restoratives. This is a regulatory submission and does not contain any inspectional observations or violations.

Company: https://www.keypedia.com/companies/parkell-inc/8eefd125-d720-4dc5-95b9-e6b6e0b2a39a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4