J. Morita USA, Inc.: FDA clearances and approvals
J. Morita USA, Inc. has 52 FDA 510(k) clearances (first 1988, latest 2022), across 27 product codes in 3 review panels. Median 510(k) review time: 100 days. Since 2017 its median was 273 days, against 116 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 234 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 242 |
| 2018 | 1 | 293 |
| 2019 | 0 | — |
| 2020 | 1 | 369 |
| 2021 | 1 | 268 |
| 2022 | 1 | 278 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, J. Morita USA, Inc.'s cleared 510(k)s took a median 273 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | 6 | 6 |
| EFB | Handpiece, Air-Powered, Dental | 5 | 5 |
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| LQY | Locator, Root Apex | 4 | 4 |
| ELR | Post, Root Canal | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
Plus 17 more product codes.
Review panels
- Dental (39)
- Radiology (12)
- General and Plastic Surgery (1)
Most recent J. Morita USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213477 | Root ZX3 | EKZ | 2022-08-03 | 278 |
| K201378 | 3D Accuitomo 150N | OAS | 2021-02-18 | 268 |
| K190509 | Lubrina 2 | EFB | 2020-03-04 | 369 |
| K173920 | LS OIL | EKX | 2018-10-11 | 293 |
| K171012 | Veraview X800 | OAS | 2017-12-19 | 259 |
| K170275 | Tri Auto ZX2 | EKX | 2017-09-11 | 224 |
| K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | GEX | 2012-07-25 | 170 |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | EKX | 2012-05-04 | 234 |
| K103697 | TORQTECH | EGS | 2012-01-20 | 396 |
| K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 | LQY | 2009-11-23 | 235 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J. Morita USA, Inc..
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 J. Morita USA, Inc. have?
J. Morita USA, Inc. has 52 FDA 510(k) clearances (first 1988, latest 2022), across 27 product codes in 3 review panels.
How long does FDA take to clear J. Morita USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across J. Morita USA, Inc.'s cleared 510(k)s is 100 days. Since 2017: 273 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does J. Morita USA, Inc. make?
Its most frequent FDA product codes are EKX (Handpiece, Direct Drive, Ac-Powered, 6); EFB (Handpiece, Air-Powered, Dental, 5); EBZ (Activator, Ultraviolet, For Polymerization, 4).
Has J. Morita USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching J. Morita USA, Inc. Related entities may recall under other names.
Next steps
- See all 52 J. Morita USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EKX, J. Morita USA, Inc.'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.