Panthera Dental, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Panthera Dental, Inc.” (first 2014, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 156 days. Since 2017 the median was 181 days, against 165 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 33 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 174 |
| 2019 | 1 | 181 |
| 2020 | 1 | 247 |
| 2021 | 1 | 132 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Panthera Dental, Inc. took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| LRK | Device, Anti-Snoring | 2 | 2 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (6)
Most recent Panthera Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203596 | Panthera Occlusal Appliance | MQC | 2021-04-20 | 132 |
| K192108 | Panthera Dental Milled Bars | NHA | 2020-04-08 | 247 |
| K183580 | Panthera Dental Milled Bars | NHA | 2019-06-20 | 181 |
| K171576 | The Panthera Anti-Snoring X3 Device | LRK | 2018-02-22 | 268 |
| K173466 | Panthera Dental Milled Bars | NHA | 2018-01-26 | 79 |
| K143244 | The Panthera Anti-Snoring Device | LRK | 2014-12-15 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Panthera Dental, 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.
Device clinical trials
An industry sponsor named Panthera Dental, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05461417: Long-term Efficacy, Tolerance and Compliance of Panthera D-SAD® Mandibular Advancement Orthosis in Sleep Apnea (Active not recruiting, started 2022-04-07)
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.
- Panthera AB (1 510(k)s)
- Panthera Production AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Panthera Dental, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Panthera Dental, Inc.” (first 2014, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Panthera Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Panthera Dental, Inc. is 156 days. Since 2017: 181 days, versus 165 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Panthera Dental, Inc.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 3); LRK (Device, Anti-Snoring, 2); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 6 Panthera Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Panthera Dental, 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.