J. MORITA USA, INC.

FDA Device Registration & Listing · IRVINE, CA, US · Registration 2081055

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2081055
FEI Number
2081055
Entity Name
J. MORITA USA, INC.
City/State/Country
IRVINE, CA, US
Establishment Address
9 MASON, IRVINE, CA 92618, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
J. MORITA USA (Owner Number: 8030247)
Owner / Operator Contact Address
9 Mason, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K964692
PMA Number
N/A

All Registered Proprietary Names

SilkLine Soft Denture Relining Material Foundation RootFlex GF Glass Fiber Post CB Temp Temporary Crown & Bridge Material Perfectim Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2006-08-22
EKM Gutta-Percha Dental Class 1 872.3850 2026-04-27
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2014-07-23
EIA Unit, Operative Dental Dental Class 1 872.6640 2025-03-21
EKN Point, Paper, Endodontic Dental Class 1 872.3830 2026-04-27
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2025-06-18
ELR Post, Root Canal Dental Class 1 872.3810 2008-04-03
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2007-12-07
ELW Material, Impression Dental Class 2 872.3660 2007-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

J. MORITA USA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006606966 J. MORITA CORP. TARUMI-CHO Osaka, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K052493 Steiner Laboratories SOCKET GRAFT 2006-06-09
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

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Registration Number Establishment Name Location
3017374693 STRATASYS LTD - Headquarter Rehovot Central, IL
2950685 CO-ORAL-ITE DENTAL MFG. CO. DIAMOND SPRINGS, CA, US
3032727 TALON ACRYLICS, INC. Winchester, OR, US
3008320092 Shandong Huge Dental Material Corporation Rizhao Shandong, CN
1410097 GC AMERICA INC. ALSIP, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2081055. Last updated year: 2026. Please use registration number 2081055 when referencing this establishment in official correspondence.
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