DX3000-L Digital Extraoral X-Ray System
510(k) K133007
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133007 | Date24 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K133007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- DX3000-L
- 510(k) Number
- FDA product code
- MUH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DX3000-L is a digital extraoral X-ray system designed for dental imaging. It employs an extraoral X-ray source to capture high-resolution images of dental structures, including panoramic and cephalometric views, aiding in diagnostic assessments for dental professionals.
This device is intended for use in dental clinics and offices, providing single-use or reusable components as specified by the manufacturer. It is classified as a Class II medical device under FDA regulations (21 CFR 872.1800) and holds an FDA 510(k) clearance (K133007) with a Special Advisory Committee classification. The system operates with multiple FEI numbers (e.g., 3000190675, 3038718579) and is supplied with specific model references for regulatory tracking.
Devices cleared under K133007
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 | |||
|---|---|---|---|---|
| DX3000; iRay; iRay D3 | DX3000 | 08800000500003 | — | On the market |
Similar devices
Other devices filed under FDA product code MUH (System, X-Ray, Extraoral Source, Digital).
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- Dental Image Plate Scanner, Model DFC-4T-SMART by Hefei Dentafilm Medical Equipment Co., Ltd.
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- PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6, 7, 8). by Progeny, Inc.
- EDLEN IMAGING - GEMINI DUSB by Edlen Imaging, LLC
- CDR PANX, MODEL 4792 by Schick Technologies, Inc.
- MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM by SIRONA Dental Systems GmbH
- TROPHYPAN by Trophy Radiologie