Planmeca Oy: FDA clearances and approvals
Planmeca Oy has 28 FDA 510(k) clearances (first 1993, latest 2023), across 6 product codes in 2 review panels. Median 510(k) review time: 82 days. Since 2017 its median was 226 days, against 119 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 87 |
| 2015 | 0 | — |
| 2016 | 1 | 86 |
| 2017 | 1 | 187 |
| 2018 | 1 | 90 |
| 2019 | 0 | — |
| 2020 | 1 | 272 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 266 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Planmeca Oy's cleared 510(k)s took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 13 | 13 |
| MUH | System, X-Ray, Extraoral Source, Digital | 5 | 5 |
| EIA | Unit, Operative Dental | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
Review panels
Most recent Planmeca Oy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230985 | Planmeca Viso | OAS | 2023-12-28 | 266 |
| K200572 | Planmeca Romexis | LLZ | 2020-12-02 | 272 |
| K181576 | Planmeca Viso | OAS | 2018-09-13 | 90 |
| K171385 | Planmeca Romexis | LLZ | 2017-11-14 | 187 |
| K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | OAS | 2016-05-20 | 86 |
| K140713 | PLANMECA ROMEXIS | LLZ | 2014-06-16 | 87 |
| K103689 | PLANMECA PROMAX 3D MID | MUH | 2011-03-17 | 90 |
| K093590 | PLANMECA PROMAX 3D MAX | MUH | 2010-05-12 | 174 |
| K091197 | PLANMECA PROSENSOR | EHD | 2009-07-29 | 97 |
| K072244 | PLANMECA PROONE | MUH | 2007-09-21 | 39 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Planmeca Oy.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Planmeca Oy have?
Planmeca Oy has 28 FDA 510(k) clearances (first 1993, latest 2023), across 6 product codes in 2 review panels.
How long does FDA take to clear Planmeca Oy's 510(k)s?
The median time from FDA receipt to decision across Planmeca Oy's cleared 510(k)s is 82 days. Since 2017: 226 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Planmeca Oy make?
Its most frequent FDA product codes are EHD (Unit, X-Ray, Extraoral With Timer, 13); MUH (System, X-Ray, Extraoral Source, Digital, 5); EIA (Unit, Operative Dental, 3).
Has Planmeca Oy had device recalls?
openFDA lists no recalls under a recalling firm name matching Planmeca Oy. Related entities may recall under other names.
Next steps
- See all 28 Planmeca Oy clearances with predicates and recalls
- Run predicate analysis for product code EHD, Planmeca Oy's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.