510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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J. Morita USA, Inc.

Irvine, CA, US

J. MORITA USA, INC. appears in FDA device records in Irvine, CA. FDA records list 52 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
52
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 52

FDA records hold 52 510(k) clearances for J. Morita USA, Inc. between 1988 and 2022. The busiest year on record is 2002, with 7. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for J. Morita USA, Inc., by decision year
YearClearances
19881
19901
19931
19951
19962
19972
19981
19991
20003
20027
20032
20041
20056
20066
20073
20083
20092
20123
20172
20181
20201
20211
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K213477Root ZX3EKZSubstantially Equivalent
K2013783D Accuitomo 150NOASSubstantially Equivalent
K190509Lubrina 2EFBSubstantially Equivalent
K173920LS OILEKXSubstantially Equivalent
K171012Veraview X800OASSubstantially Equivalent
K170275Tri Auto ZX2EKXSubstantially Equivalent
K120377ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-AGEXSubstantially Equivalent
K112665TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECEEKXSubstantially Equivalent
K103697TORQTECHEGSSubstantially Equivalent
K090925MULTIPLE (APEX LOCATOR), MODEL RCM-7LQYSubstantially Equivalent
K091065AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4EFBSubstantially Equivalent
K0736953D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17JAKSubstantially Equivalent
K073696VERAVIEWEPOCSMUHSubstantially Equivalent
K073704I-DIXELLLZSubstantially Equivalent
K071190ROOT ZX IIEKXSubstantially Equivalent
K070074LUBRINA, MODEL HIM-1EFBSubstantially Equivalent
K063529PENCURE, MODEL VL-7EBZSubstantially Equivalent
K061664FORMCORE DC, MODEL 28-700100EBFSubstantially Equivalent
K060882EXCEL BOND DC, MODEL 28-200100KLESubstantially Equivalent
K061701HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)EFASubstantially Equivalent
K060844SILKLINE SOFT RELINING KIT, MODEL 28-100100EBISubstantially Equivalent
K061322PORCELAIN PRIMERKLESubstantially Equivalent
K053220VERAVIEW IC 5, MODEL XDP1MUHSubstantially Equivalent
K0525873D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXFJAKSubstantially Equivalent
K053030J. MORITA AZ ULTRASONIC SYSTEMELCSubstantially Equivalent
K051780JETLITE 5000EBZSubstantially Equivalent
K043497AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OVEFBSubstantially Equivalent
K043498TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECEEFBSubstantially Equivalent
K043496SPACELINE EMCIA, MODEL CU580EIASubstantially Equivalent
K042056AZ ULTRASONIC SYSTEMELCSubstantially Equivalent
K031204DENTAPORT ZXEKXSubstantially Equivalent
K0304503D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPHJAKSubstantially Equivalent
K022147DENTA PORTLQYSubstantially Equivalent
K021372VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYEAGSubstantially Equivalent
K012496CARBON POSTELRSubstantially Equivalent
K012849GLASS POSTELRSubstantially Equivalent
K020158NON-EUGENOL TEMPORARY CEMENTEMBSubstantially Equivalent
K020157TEMPORARY CROWN AND BRIDGE MATERIALEBGSubstantially Equivalent
K013955VERAVIEWEPOCS, MODEL VEEHDSubstantially Equivalent
K002640FREEDOM AUTOMATIC FILM PROCESSORIXWSubstantially Equivalent
K000078JETLITE 4000EBZSubstantially Equivalent
K992648ROTARY MASTEREBWSubstantially Equivalent
K992649ATD AUTOMATIC BRIDGE REMOVEREISSubstantially Equivalent
K974077VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.EHDSubstantially Equivalent
K970339TRI AUTO ZXEKXSubstantially Equivalent
K964692PERFECTIMELWSubstantially Equivalent
K963110JETLITEEBZSubstantially Equivalent
K953865SPACELINE FEEL 21EFASubstantially Equivalent
K953867ROOT CANAL LENGTH MEASURING DEVICELQYSubstantially Equivalent
K921979ROOT ZXLQYSubstantially Equivalent

Registered establishments

FDA registered establishments for J. Morita USA, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20810552081055J. MORITA USA, INC.9 MASON, IRVINE, CA 92618 US2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain