FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERAVIEWEPOCS, MODEL VE
K Number: K013955
·
Decision Feb 4, 2002
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
52
Review Days
66
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
- VERAVIEWEPOCS, MODEL VE
- K Number
- K013955
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. Morita USA, Inc.
- Date Received
- November 30, 2001
- Decision Date
- February 4, 2002
- Product Code
- EHD
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by J. Morita USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213477 | Root ZX3 | Aug 3, 2022 | Substantially Equivalent |
| K201378 | 3D Accuitomo 150N | Feb 18, 2021 | Substantially Equivalent |
| K190509 | Lubrina 2 | Mar 4, 2020 | Substantially Equivalent |
| K173920 | LS OIL | Oct 11, 2018 | Substantially Equivalent |
| K171012 | Veraview X800 | Dec 19, 2017 | Substantially Equivalent |
| K170275 | Tri Auto ZX2 | Sep 11, 2017 | Substantially Equivalent |
| K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | Jul 25, 2012 | Substantially Equivalent |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | May 4, 2012 | Substantially Equivalent |
| K103697 | TORQTECH | Jan 20, 2012 | Substantially Equivalent |
| K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 | Nov 23, 2009 | Substantially Equivalent |