XERO-alpha
510(k) K242591
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242591 | Date1 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K242591
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The XERO-alpha is an Extraoral X-Ray Unit With Timer, classified under product code EHD. This device is designed for dental radiography, capturing high-quality images of teeth and surrounding structures using extraoral techniques. Its timer function ensures precise exposure control for consistent imaging results.
Supplied as a reusable Class II medical device, the XERO-alpha is intended for use in dental offices and clinics. It operates under regulatory oversight as defined by 21 CFR 872.1800, with an FDA 510(k) clearance (K242591) granted on November 1, 2024. The device requires proper maintenance and calibration to ensure compliance with safety and performance standards.
Devices cleared under K242591
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| XERO-alpha XERO α | XERO α | 08800018424704 | — | On the market |
Similar devices
Other devices filed under FDA product code EHD (Unit, X-Ray, Extraoral With Timer).
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