Cephalometer
The Cephalometer is a dental and orthodontic device used to precisely position a patient's head for standardized cephalometric radiographic imaging, enabling measurement of craniofacial skeletal relationships for orthodontic diagnosis and treatment planning. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EAG and the applicable regulation is 21 CFR 872.1830, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- EAG
- Device Class
- FDA class 2
- Regulation Number
- 872.1830
- Medical Specialty
- Dental
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K030699 | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC | May 29, 2003 | Substantially Equivalent | J. Morita Mfg. Corp. |
| K021372 | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY | Jun 07, 2002 | Substantially Equivalent | J. Morita USA, Inc. |
| K944162 | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Nov 29, 1994 | Substantially Equivalent | Teledyne Water Pik |
| K920189 | GX-C CEPHALOMETER | Apr 28, 1992 | Substantially Equivalent | Gendex Corp. |
| K896099 | DIGIGRAPH DIAGNOSTIC WORK/STATION | Jan 31, 1991 | Substantially Equivalent | Dolphin Imaging Systems |
| K870243 | BURNETT TMJ APPLIANCE | Feb 24, 1987 | Substantially Equivalent | Medrad, Inc. |
| K842463 | GX CEPH | Aug 02, 1984 | Substantially Equivalent | Gendex Corp. |
| K833006 | CEPHALOMETER & FIXATOR | Jan 03, 1984 | Substantially Equivalent | Modern Systems, Inc. |
| K810538 | PLASTICEPH | Apr 29, 1981 | Substantially Equivalent | Morningstar Dental Co. |
| K781287 | DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH | Sep 11, 1978 | Substantially Equivalent | Siemens Corp. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.