FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DX3000-L
K Number: K133007
·
Decision Apr 24, 2014
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
5
Review Days
211
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DX3000-L
- K Number
- K133007
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dexcowin Co., Ltd.
- Date Received
- September 25, 2013
- Decision Date
- April 24, 2014
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.
SOTA Cloud Smart Sensor (1.5)
FDA 510(k)
FDA Class 2
·Dental
EzSensor HD, EzSensor UHD
FDA 510(k)
FDA Class 2
·Dental
Cocoon Solo (DX-7020s)
FDA 510(k)
FDA Class 2
·Dental
Digital X-Ray DentiMax Pro Imaging System
FDA 510(k)
FDA Class 2
·Dental
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
FDA 510(k)
FDA Class 2
·Dental
X Sensor (Model: IOS-A15IF, HDI-15DGF)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dexcowin Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K173046 | Cocoon Portable Handheld X-Ray System | Oct 26, 2017 | Substantially Equivalent |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | Oct 5, 2015 | Substantially Equivalent |
| K134055 | ADX4000W | May 9, 2014 | Substantially Equivalent |
| K083532 | ADX4000-L, DX3000-L | Mar 10, 2009 | Substantially Equivalent |