Heliodent DS
FDA 510(k) K960819 · Pelton & Crane Co.
510(k) numberK960819
Submission
- Device name
- Heliodent DS
- Applicant
- Pelton & Crane Co.
Charlotte, NC, US - Received
- February 29, 1996
- Decision date
- March 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| 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 |
| K951734 | Lumix 70BEAP · Traditional | Emix U.S.A., Inc. | 07/20/1995SE |
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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 |
| 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 |
| K936068 | Orthophos 3/ Orthophos 3CEAP · Traditional | 07/29/1994SE |
Questions and answers
When was Heliodent DS cleared by the FDA?
Heliodent DS (K960819) received a 510(k) decision of Substantially Equivalent on March 29, 1996, 29 days after the submission was received.
What is the product code of K960819?
The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.