Orthophos 3/ Orthophos 3C
FDA 510(k) K936068 · Pelton & Crane Co.
510(k) numberK936068
Submission
- Device name
- Orthophos 3/ Orthophos 3C
- Applicant
- Pelton & Crane Co.
Charlotte, NC, US - Received
- December 21, 1993
- Decision date
- July 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
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| K171872 | P50 Series Dental Operative Unit and AccessoriesEIA · Traditional | 04/26/2018SE |
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| K972249 | Orthophos Plus and Orthophos Plus/CdEHD · Traditional | 09/12/1997SE |
| K972168 | Sidexis Digital Radiography SystemEHD · Traditional | 09/05/1997SE |
| K945117 | DeltaFLE · Traditional | 02/28/1997SE |
| K962071 | Spirit S1/S2EIA · Traditional | 08/06/1996SE |
| K960819 | Heliodent DSEAP · Traditional | 03/29/1996SE |
| K950299 | Cerec 2ELW · Traditional | 05/23/1995SE |
| K946187 | Spirit II and Spirit Treatment CenterEIA · Traditional | 03/01/1995SE |
| K950030 | Heliodent MDEAP · Traditional | 02/03/1995SE |
Questions and answers
When was Orthophos 3/ Orthophos 3C cleared by the FDA?
Orthophos 3/ Orthophos 3C (K936068) received a 510(k) decision of Substantially Equivalent on July 29, 1994, 220 days after the submission was received.
What is the product code of K936068?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.