EAG — Cephalometer Class II
FDA product code EAG covers "Cephalometer", a Class II medical device regulated under 21 CFR 872.1830. Submissions are reviewed by the Dental panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EAG
- Device Class
- Class II
- Regulation Number
- 872.1830
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030699 | j. morita mfg | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC | May 29, 2003 |
| K021372 | j. morita usa | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | June 7, 2002 |
| K944162 | teledyne water pik | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | November 29, 1994 |
| K920189 | gendex | GX-C CEPHALOMETER | April 28, 1992 |
| K896099 | dolphin imaging systems | DIGIGRAPH DIAGNOSTIC WORK/STATION | January 31, 1991 |
| K870243 | medrad | BURNETT TMJ APPLIANCE | February 24, 1987 |
| K842463 | gendex | GX CEPH | August 2, 1984 |
| K833006 | modern systems | CEPHALOMETER & FIXATOR | January 3, 1984 |
| K810538 | morningstar dental | PLASTICEPH | April 29, 1981 |
| K781287 | siemens | DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH | September 11, 1978 |