Company ยท US
J. Morita USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2022. Name variants (Inc, Corp, punctuation) are merged.
52510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | 6 |
| EFB | Handpiece, Air-Powered, Dental | 5 |
| EBZ | Activator, Ultraviolet, For Polymerization | 4 |
| LQY | Locator, Root Apex | 4 |
| ELR | Post, Root Canal | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 |
| ELC | Scaler, Ultrasonic | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 |
| OAS | X-Ray, Tomography, Computed, Dental | 2 |
| EAG | Cephalometer | 1 |
| EBF | Material, Tooth Shade, Resin | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| EIA | Unit, Operative Dental | 1 |
| EIS | Remover, Crown | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2022 | K213477 | Root ZX3 J. Morita USA, Inc. | EKZ |
| Feb 18, 2021 | K201378 | 3D Accuitomo 150N J. Morita USA, Inc. | OAS |
| Mar 4, 2020 | K190509 | Lubrina 2 J. Morita USA, Inc. | EFB |
| Oct 11, 2018 | K173920 | LS OIL J. Morita USA, Inc. | EKX |
| Dec 19, 2017 | K171012 | Veraview X800 J. Morita USA, Inc. | OAS |
| Sep 11, 2017 | K170275 | Tri Auto ZX2 J. Morita USA, Inc. | EKX |
| Jul 25, 2012 | K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A J. Morita USA, Inc. | GEX |
| May 4, 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE J. Morita USA, Inc. | EKX |
| Jan 20, 2012 | K103697 | TORQTECH J. Morita USA, Inc. | EGS |
| Nov 23, 2009 | K090925 | MULTIPLE (APEX LOCATOR), MODEL RCM-7 J. Morita USA, Inc. | LQY |
| Oct 16, 2009 | K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 J. Morita USA, Inc. | EFB |
| Apr 9, 2008 | K073695 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 J. Morita USA, Inc. | JAK |
| Apr 8, 2008 | K073696 | VERAVIEWEPOCS J. Morita USA, Inc. | MUH |
| Feb 21, 2008 | K073704 | I-DIXEL J. Morita USA, Inc. | LLZ |
| Aug 17, 2007 | K071190 | ROOT ZX II J. Morita USA, Inc. | EKX |
| May 31, 2007 | K070074 | LUBRINA, MODEL HIM-1 J. Morita USA, Inc. | EFB |
| Jan 5, 2007 | K063529 | PENCURE, MODEL VL-7 J. Morita USA, Inc. | EBZ |
| Sep 8, 2006 | K061664 | FORMCORE DC, MODEL 28-700100 J. Morita USA, Inc. | EBF |
| Sep 1, 2006 | K060882 | EXCEL BOND DC, MODEL 28-200100 J. Morita USA, Inc. | KLE |
| Aug 25, 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) J. Morita USA, Inc. | EFA |
| Jun 6, 2006 | K060844 | SILKLINE SOFT RELINING KIT, MODEL 28-100100 J. Morita USA, Inc. | EBI |
| Jun 2, 2006 | K061322 | PORCELAIN PRIMER J. Morita USA, Inc. | KLE |
| Jan 6, 2006 | K053220 | VERAVIEW IC 5, MODEL XDP1 J. Morita USA, Inc. | MUH |
| Dec 27, 2005 | K052587 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. Morita USA, Inc. | JAK |
| Nov 7, 2005 | K053030 | J. MORITA AZ ULTRASONIC SYSTEM J. Morita USA, Inc. | ELC |
| Jul 28, 2005 | K051780 | JETLITE 5000 J. Morita USA, Inc. | EBZ |
| Mar 21, 2005 | K043497 | AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV J. Morita USA, Inc. | EFB |
| Feb 16, 2005 | K043498 | TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE J. Morita USA, Inc. | EFB |
| Feb 16, 2005 | K043496 | SPACELINE EMCIA, MODEL CU580 J. Morita USA, Inc. | EIA |
| Sep 30, 2004 | K042056 | AZ ULTRASONIC SYSTEM J. Morita USA, Inc. | ELC |
| Aug 21, 2003 | K031204 | DENTAPORT ZX J. Morita USA, Inc. | EKX |
| May 6, 2003 | K030450 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH J. Morita USA, Inc. | JAK |
| Dec 20, 2002 | K022147 | DENTA PORT J. Morita USA, Inc. | LQY |
| Jun 7, 2002 | K021372 | VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY J. Morita USA, Inc. | EAG |
| May 17, 2002 | K012496 | CARBON POST J. Morita USA, Inc. | ELR |
| Mar 27, 2002 | K012849 | GLASS POST J. Morita USA, Inc. | ELR |
| Mar 7, 2002 | K020158 | NON-EUGENOL TEMPORARY CEMENT J. Morita USA, Inc. | EMB |
| Mar 4, 2002 | K020157 | TEMPORARY CROWN AND BRIDGE MATERIAL J. Morita USA, Inc. | EBG |
| Feb 4, 2002 | K013955 | VERAVIEWEPOCS, MODEL VE J. Morita USA, Inc. | EHD |
| Nov 8, 2000 | K002640 | FREEDOM AUTOMATIC FILM PROCESSOR J. Morita USA, Inc. | IXW |
| May 15, 2000 | K000078 | JETLITE 4000 J. Morita USA, Inc. | EBZ |
| Jan 31, 2000 | K992648 | ROTARY MASTER J. Morita USA, Inc. | EBW |
| Oct 29, 1999 | K992649 | ATD AUTOMATIC BRIDGE REMOVER J. Morita USA, Inc. | EIS |
| Jan 20, 1998 | K974077 | VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. J. Morita USA, Inc. | EHD |
| Jun 4, 1997 | K970339 | TRI AUTO ZX J. Morita USA, Inc. | EKX |
| Feb 25, 1997 | K964692 | PERFECTIM J. Morita USA, Inc. | ELW |
| Oct 24, 1996 | K963110 | JETLITE J. Morita USA, Inc. | EBZ |
| Mar 20, 1996 | K953865 | SPACELINE FEEL 21 J. Morita USA, Inc. | EFA |
| Dec 1, 1995 | K953867 | ROOT CANAL LENGTH MEASURING DEVICE J. Morita USA, Inc. | LQY |
| May 27, 1993 | K921979 | ROOT ZX J. Morita USA, Inc. | LQY |
Newest 50 of 52.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||