Planmeca Proone
FDA 510(k) K072244 · Planmeca Oy
510(k) numberK072244
Submission
- Device name
- Planmeca Proone
- Applicant
- Planmeca Oy
Helsinki, FI - Received
- August 13, 2007
- Decision date
- September 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Dental Imaging Technologies Corporation
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| K230985 | Planmeca VisoOAS · Traditional | 12/28/2023SE |
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| K181576 | Planmeca VisoOAS · Traditional | 09/13/2018SE |
| K171385 | Planmeca RomexisLLZ · Traditional | 11/14/2017SE |
| K160506 | Planmeca ProMax 3D Max, Planmeca MaximityOAS · Traditional | 05/20/2016SE |
| K140713 | Planmeca RomexisLLZ · Traditional | 06/16/2014SE |
| K103689 | Planmeca Promax 3D MidMUH · Traditional | 03/17/2011SE |
| K093590 | Planmeca Promax 3D MaxMUH · Traditional | 05/12/2010SE |
| K091197 | Planmeca ProsensorEHD · Traditional | 07/29/2009SE |
| K060328 | Planmeca Promax 3DMUH · Traditional | 03/15/2006SE |
Questions and answers
When was Planmeca Proone cleared by the FDA?
Planmeca Proone (K072244) received a 510(k) decision of Substantially Equivalent on September 21, 2007, 39 days after the submission was received.
What is the product code of K072244?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.