FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
K Number: K070811
·
Decision Jul 5, 2007
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
1
Review Days
101
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
- CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000
- K Number
- K070811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dexco
- Date Received
- March 26, 2007
- Decision Date
- July 5, 2007
- 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