Dentix Dental X-Ray Unit
FDA 510(k) K792307 · Precise Optics
510(k) numberK792307
Submission
- Device name
- Dentix Dental X-Ray Unit
- Applicant
- Precise Optics
Mchenry, IL, US - Received
- November 16, 1979
- Decision date
- January 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113360 | Medical Image Processing UnitEAP · Special | Humanray Co,Ltd | 02/07/2012SE |
| K102573 | Provu (TM) Dental X-Ray SystemEAP · Traditional | Advanced Image Science, Inc. | 06/30/2011SE |
| K093453 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 11/30/2009SE |
| K080738 | Dentron SensorEAP · Traditional | Dentron Systems, LLC | 05/13/2008SE |
| K052422 | The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special | Flow X-Ray Corp. | 09/27/2005SE |
| K041385 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 06/07/2004SE |
| K960819 | Heliodent DSEAP · Traditional | Pelton & Crane Co. | 03/29/1996SE |
| K960028 | Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional | Dentsply Intl. | 03/01/1996SE |
| K953936 | AtlantisEAP · Traditional | Trophy Radiologie | 12/28/1995SE |
| K954565 | Explor-X (Azteh) HFEAP · Traditional | Chicago X-Ray Systems, Inc. | 10/27/1995SE |
More from Chicago X-Ray Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030061 | PS 3000 Digatal Photospot SystemOWB · Traditional | 04/07/2003SE |
| K935580 | PHF20 20 Mobile C-Arm Image IntensifierOXO · Traditional | 03/16/1994SE |
| K932878 | Precision Intra-Oral ScopesEIA · Traditional | 01/06/1994SE |
| K914084 | EndoscopesGCJ · Traditional | 01/22/1992SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | 11/27/1991SE |
| K911744 | Precision Optics Corporation LaparoscopeGCJ · Traditional | 07/26/1991SE |
| K903459 | Precision Optics Endoscope AdapterFET · Traditional | 10/26/1990SE |
| K903458 | Precision Optics Image CouplerFET · Traditional | 10/19/1990SE |
| K903457 | Precision Optics Image Beamsplitter (Coupler)FET · Traditional | 10/19/1990SE |
| K827087 | P1808 Mobile C-Arm Image Intensifier · Traditional | 03/04/1982SE |
Questions and answers
When was Dentix Dental X-Ray Unit cleared by the FDA?
Dentix Dental X-Ray Unit (K792307) received a 510(k) decision of Substantially Equivalent on January 9, 1980, 54 days after the submission was received.
What is the product code of K792307?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.