Eaglesoft Chairside
510(k) K982422
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK982422 | Date30 Sep 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Eaglesoft Chairside is a Dental Practice Management Software designed to streamline administrative and clinical workflows in dental offices. It integrates patient records, scheduling, billing, and insurance processing to enhance efficiency and coordination between front-desk and clinical operations.
Supplied as a Windows-based application, the Eaglesoft Chairside operates within dental practice settings and is intended for single-user or multi-user environments. Authorized for use in the United States under an FDA 510(k) clearance (K982422), it falls under the Product Code LLZ (Radiology) and was reviewed by the Radiology (RA) Advisory Committee. No sterility, single-use, or reusable specifications apply, as it is a software solution rather than a physical medical device.
Questions
AI-generated answers, 19 Sep 2026
What is the Eaglesoft Chairside intended for in a dental practice?
The Eaglesoft Chairside is a Dental Practice Management Software designed to streamline administrative and clinical workflows in dental offices by integrating patient records, scheduling, billing, and insurance processing to enhance efficiency and coordination between front-desk and clinical operations.
How is the Eaglesoft Chairside supplied and what environment is it designed for?
The Eaglesoft Chairside is supplied as a Windows-based application and is intended for use in dental practice settings, supporting both single-user and multi-user environments to accommodate varying office sizes and staffing needs.
Does the Eaglesoft Chairside have any sterility, single-use, or reuse characteristics?
No, the Eaglesoft Chairside is a software solution and therefore does not have sterility, single-use, or reusable specifications, as these attributes apply only to physical medical devices, not software.
What regulatory pathway was used for the Eaglesoft Chairside and what is its clearance status?
The Eaglesoft Chairside was authorized for use in the United States under an FDA 510(k) clearance (K982422), with a decision of Substantially Equivalent (SESE) granted on September 30, 1998, following review by the Radiology (RA) Advisory Committee.
Under which product code and advisory committee was the Eaglesoft Chairside classified during its FDA review?
The Eaglesoft Chairside falls under Product Code LLZ (Radiology) and was reviewed by the Radiology (RA) Advisory Committee during its FDA 510(k) submission process, as indicated in the device’s authorization and review details.