# J. Morita USA, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 52 (1988–2022): 52 510(k) clearances
- Product codes: EKX (6), EFB (5), EBZ (4), LQY (4), ELR (3), JAK (3), EFA (2), ELC (2), EHD (2), OAS (2), MUH (2), KLE (2)
- 510(k) review time since 2016: median 281 days, against 234 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 52 (24 its own); citations of its devices by later devices: 56 (24 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Crown Delta Corp.: 5 (https://510kreport.com/company/crown-delta)
- A-Dec, Inc.: 3 (https://510kreport.com/company/a-dec)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Kavo America: 2 (https://510kreport.com/company/kavo-america)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Instrumentarium Corp.: 2 (https://510kreport.com/company/instrumentarium)
- J. Morita Mfg. Corp.: 2 (https://510kreport.com/company/j-morita-mfg)
- Diagnostic Data, Inc.: 1 (https://510kreport.com/company/diagnostic-data)

## Firms that cite its devices most
- Sirona Dental Systems GmbH: 3 (https://510kreport.com/company/sirona-dental-systems)
- Good Doctors Co., Ltd.: 2 (https://510kreport.com/company/good-doctors)
- Nouvag AG: 2 (https://510kreport.com/company/nouvag)
- Toei Electric Co., Ltd.: 2 (https://510kreport.com/company/toei-electric)
- Imaging Sciences Intl., Inc.: 2 (https://510kreport.com/company/imaging-sciences-intl)
- Kaltenbach & Voigt GmbH: 1 (https://510kreport.com/company/kaltenbach-voigt)
- Sheaumann Laser, Inc.: 1 (https://510kreport.com/company/sheaumann-laser)
- Techdent Technologies, Ltd.: 1 (https://510kreport.com/company/techdent-technologies)

## Its most-cited devices
- K970339: Tri Auto ZX (1997), cited by 7
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph (2003), cited by 6
- K921979: Root ZX (1993), cited by 5
- K031204: Dentaport ZX (2003), cited by 4
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf (2005), cited by 4
- K071190: Root ZX II (2007), cited by 3

## Recent decisions
- K213477: Root ZX3 (Aug 3, 2022)
- K201378: 3D Accuitomo 150N (Feb 18, 2021)
- K190509: Lubrina 2 (Mar 4, 2020)
- K173920: LS OIL (Oct 11, 2018)
- K171012: Veraview X800 (Dec 19, 2017)
- K170275: Tri Auto ZX2 (Sep 11, 2017)
- K120377: Adverl Evo ER: Yag Laser for Dentistry Mey-1-a (Jul 25, 2012)
- K112665: Tri Auto Mini - Endodeontic Treatment Motorized Handpiece (May 4, 2012)

Source page: https://510kreport.com/company/j-morita-usa