Plasticeph
FDA 510(k) K810538 · Morningstar Dental Co.
510(k) numberK810538
Submission
- Device name
- Plasticeph
- Applicant
- Morningstar Dental Co.
Mchenry, IL, US - Received
- February 26, 1981
- Decision date
- April 29, 1981
- 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 |
| K870243 | Burnett TMJ ApplianceEAG · Traditional | Medrad, Inc. | 02/24/1987SE |
| K842463 | GX CephEAG · Traditional | Gendex Corp. | 08/02/1984SE |
| K833006 | Cephalometer & FixatorEAG · Traditional | Modern Systems, Inc. | 01/03/1984SE |
| K781287 | Dental X-Ray Unit W/Cephalometric AttachEAG · Traditional | Siemens Corp. | 09/11/1978SE |
Questions and answers
When was Plasticeph cleared by the FDA?
Plasticeph (K810538) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 62 days after the submission was received.
What is the product code of K810538?
The FDA product code is EAG – Cephalometer, a Class II (moderate risk) device regulated under 21 CFR 872.1830.