FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GXP DENTAL X-RAY PROCESSOR
K Number: K932675
·
Decision Jul 26, 1993
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
6
Applicant Total
14
Review Days
54
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
- GXP DENTAL X-RAY PROCESSOR
- K Number
- K932675
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gendex Corp.
- Date Received
- June 2, 1993
- Decision Date
- July 26, 1993
- Product Code
- EGN
- 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 |
|---|---|---|---|
| EGN | Scissors, Surgical Tissue, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGN), ordered by most recent decision date.
1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS
FDA 510(k)
FDA Class 1
·Dental
MAYO SCISSOR CURYED 5 1/2
FDA 510(k)
FDA Class 1
·Dental
MAYO SCISSOR STRAIGHT 5 1/2
FDA 510(k)
FDA Class 1
·Dental
TONSIL SCISSORS STRAIGHT 5 1/2
FDA 510(k)
FDA Class 1
·Dental
TONSIL SCISSORS 7
FDA 510(k)
FDA Class 1
·Dental
CONPHAR
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Gendex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K952598 | GX-PAN PANORAMIC DENTAL X-RAY SYSTEM | Jun 29, 1995 | Substantially Equivalent |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | Feb 9, 1995 | Substantially Equivalent |
| K935046 | GX-770 X-RAY CONTROL, MODEL 46-404600G4 | Feb 18, 1994 | Substantially Equivalent |
| K925094 | VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS | Sep 29, 1993 | Substantially Equivalent |
| K931001 | ORALIX DC | Sep 14, 1993 | Substantially Equivalent |
| K922165 | ATC725, ATC525, AND AP300 | Jul 27, 1992 | Substantially Equivalent |
| K920189 | GX-C CEPHALOMETER | Apr 28, 1992 | Substantially Equivalent |
| K894188 | GX-ELEVATOR | Oct 3, 1989 | Substantially Equivalent |
| K890083 | GX-2000 STATIONARY X-RAY GENERATOR | Mar 31, 1989 | Substantially Equivalent |
| K873982 | GX-MOBILE X-RAY UNIT | Oct 30, 1987 | Substantially Equivalent |