Planmeca USA, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Planmeca USA, Inc.” (first 1984, latest 2011), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIA | Unit, Operative Dental | 3 | 3 |
| KLC | Chair, Dental, With Operative Unit | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| EBA | Light, Surgical Headlight | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (7)
- Radiology (4)
- Anesthesiology (1)
Most recent Planmeca USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111361 | PLANMED NUANCE EXCEL | MUE | 2011-09-23 | 130 |
| K081699 | PLANMECA SOVEREIGN | EIA | 2008-08-29 | 73 |
| K923534 | PM2002 PROLINE | KLC | 1994-01-31 | 564 |
| K923533 | ADMARK | JAC | 1993-03-04 | 231 |
| K923462 | DELIGHT | EAZ | 1992-12-21 | 160 |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | KLC | 1992-12-21 | 160 |
| K904953 | PLANMED SOPHIE | IZH | 1991-04-18 | 164 |
| K904948 | PM2002 CC AND PM2002 EC | EIA | 1991-01-30 | 90 |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | BZG | 1991-01-30 | 90 |
| K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | EHD | 1986-11-26 | 13 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Planmeca USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Planmeca Oy (28 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Planmeca USA, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Planmeca USA, Inc.” (first 1984, latest 2011), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Planmeca USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Planmeca USA, Inc. is 90 days.
Which FDA product codes appear under Planmeca USA, Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 3); KLC (Chair, Dental, With Operative Unit, 2); BZG (Spirometer, Diagnostic, 1).
Next steps
- See all 13 Planmeca USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Planmeca USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.