FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K Number: K972249
·
Decision Sep 12, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
14
Review Days
88
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
- ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
- K Number
- K972249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pelton & Crane Co.
- Date Received
- June 16, 1997
- Decision Date
- September 12, 1997
- 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 Pelton & Crane Co.
| K Number | Device Name | ||
|---|---|---|---|
| K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | Sep 5, 1997 | Substantially Equivalent |
| K945117 | DELTA | Feb 28, 1997 | Substantially Equivalent |
| K962071 | SPIRIT S1/S2 | Aug 6, 1996 | Substantially Equivalent |
| K960819 | HELIODENT DS | Mar 29, 1996 | Substantially Equivalent |
| K950299 | CEREC 2 | May 23, 1995 | Substantially Equivalent |
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | Mar 1, 1995 | Substantially Equivalent |
| K950030 | HELIODENT MD | Feb 3, 1995 | Substantially Equivalent |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Jul 29, 1994 | Substantially Equivalent |
| K935390 | SIROLUX FANTASTIC | Dec 10, 1993 | Substantially Equivalent |
| K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT | Jul 6, 1990 | Substantially Equivalent |