PREXION3D Eclipse
by The Yoshida Dental Mfg. Co., Ltd.
510(k) K122199
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122199 | Date18 Apr 2013 | 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- Withdrawn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
- OAS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Prexion3d Eclipse is a Class II dental computed tomography X-ray system. It is designed to produce two-dimensional digital panoramic and cephalometric images, as well as three-dimensional digital X-ray images of the dentomaxillofacial area.
This device has received FDA 510(k) clearance under the regulation number 892.1750. It is manufactured by The Yoshida Dental Mfg. Co., Ltd. and is categorized under the radiology medical specialty.
Other devices from The Yoshida Dental Mfg. Co., Ltd.
Questions
AI-generated answers, 21 Sep 2026
What is the primary clinical use of the Prexion3d Eclipse?
The Prexion3d Eclipse is a dental computed tomography X-ray system used to capture two-dimensional digital panoramic and cephalometric images, as well as three-dimensional digital X-ray images of the dentomaxillofacial area.
What is the regulatory status of this device?
The Prexion3d Eclipse has received FDA 510(k) clearance under regulation number 892.1750. It is classified as a Class II medical device within the radiology specialty.
Who is the manufacturer of the Prexion3d Eclipse?
The device is manufactured by The Yoshida Dental Mfg. Co., Ltd., located in Chiyoda-Ku, Tokyo, Japan.