Planmeca Viso
X-ray, Tomography, Computed, Dental
Planmeca Oy
The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Viso.
Pre-market Notification Details
| Device ID | K181576 |
| 510k Number | K181576 |
| Device Name: | Planmeca Viso |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Planmeca Oy Asentajankatu 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring Planmeca Oy Asentajankatu 6 Helsinki, FI 00880 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2018-09-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035420605 | K181576 | 000 |
| 06430035420551 | K181576 | 000 |
Trademark Results [Planmeca Viso]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLANMECA VISO 79228812 5870359 Live/Registered |
Planmeca Oy 2017-09-22 |
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