Burnett TMJ Appliance
FDA 510(k) K870243 · Medrad, Inc.
510(k) numberK870243
Submission
- Device name
- Burnett TMJ Appliance
- Applicant
- Medrad, Inc.
Pittsburgh, PA, US - Received
- January 21, 1987
- Decision date
- February 24, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030699 | Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricEAG · Traditional | J. Morita Mfg. Corp. | 05/29/2003SE |
| K021372 | Veraviewepocs Panoramic X-Ray Unit with Cephalometric CapabilityEAG · Traditional | J. Morita USA, Inc. | 06/07/2002SE |
| K944162 | Denar Accuceph Cephalometer Imaging SystemEAG · Traditional | Teledyne Water Pik | 11/29/1994SE |
| K920189 | Gx-C CephalometerEAG · Traditional | Gendex Corp. | 04/28/1992SE |
| K896099 | Digigraph Diagnostic Work/StationEAG · Traditional | Dolphin Imaging Systems | 01/31/1991SE |
| K842463 | GX CephEAG · Traditional | Gendex Corp. | 08/02/1984SE |
| K833006 | Cephalometer & FixatorEAG · Traditional | Modern Systems, Inc. | 01/03/1984SE |
| K810538 | PlasticephEAG · Traditional | Morningstar Dental Co. | 04/29/1981SE |
| K781287 | Dental X-Ray Unit W/Cephalometric AttachEAG · Traditional | Siemens Corp. | 09/11/1978SE |
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Questions and answers
When was Burnett TMJ Appliance cleared by the FDA?
Burnett TMJ Appliance (K870243) received a 510(k) decision of Substantially Equivalent on February 24, 1987, 34 days after the submission was received.
What is the product code of K870243?
The FDA product code is EAG – Cephalometer, a Class II (moderate risk) device regulated under 21 CFR 872.1830.