Denar Accuceph Cephalometer Imaging System
FDA 510(k) K944162 · Teledyne Water Pik
510(k) numberK944162
Submission
- Device name
- Denar Accuceph Cephalometer Imaging System
- Applicant
- Teledyne Water Pik
Fort Collins, CO, US - Received
- August 26, 1994
- Decision date
- November 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K920189 | Gx-C CephalometerEAG · Traditional | Gendex Corp. | 04/28/1992SE |
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| 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 |
| 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 Denar Accuceph Cephalometer Imaging System cleared by the FDA?
Denar Accuceph Cephalometer Imaging System (K944162) received a 510(k) decision of Substantially Equivalent on November 29, 1994, 95 days after the submission was received.
What is the product code of K944162?
The FDA product code is EAG – Cephalometer, a Class II (moderate risk) device regulated under 21 CFR 872.1830.