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J. MORITA U.S.A., INC

US

Last updated May 31, 2026

What J. MORITA U.S.A., INC makes

J. Morita U.S.A., Inc. manufactures dental impression materials, including silicone-based systems for creating precise oral scans, as well as disposable and reusable instruments like single-use syringes and cheek retractors for professional use. Their portfolio also includes bonding agents for dentine, soft denture reliners, root canal post kits, zinc oxide eugenol cement, and dental composite resins for restorative procedures.

The company’s devices are regulated under FDA’s classification system, with products falling into Class I and Class II categories, and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices in dentistry.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does J. Morita U.S.A., Inc. manufacture?

J. Morita U.S.A., Inc. specializes in dental devices, including silicone-based impression materials for creating detailed oral scans, single-use syringes, reusable cheek retractors, dentine bonding agents, soft denture reliners, root canal post kits, zinc oxide eugenol cement, and dental composite resins. These products are designed for professional dental procedures and restorative treatments.

Where is J. Morita U.S.A., Inc. based, and how does that affect its devices?

J. Morita U.S.A., Inc. is based in the United States, meaning its devices are subject to U.S. regulatory requirements, including FDA oversight. The company’s products are developed and distributed in compliance with applicable U.S. medical device regulations, ensuring they meet safety, performance, and labeling standards for dental use.

Which regulatory registries list J. Morita U.S.A., Inc.’s devices?

J. Morita U.S.A., Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices’ compliance with U.S. regulatory requirements.

How are J. Morita U.S.A., Inc.’s devices classified under FDA regulations?

J. Morita U.S.A., Inc.’s devices are classified under the FDA’s system as either Class I or Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional controls due to moderate risk, such as special labeling or performance standards. The classification depends on factors like the device’s intended use and potential health impact.

What kinds of dental materials and tools does J. Morita U.S.A., Inc. provide for root canal treatments?

For root canal treatments, J. Morita U.S.A., Inc. offers root canal post kits, which include components like posts and cement for restoring treated teeth. These kits are designed to provide structural support and seal the canal, ensuring long-term stability and functionality. The company also provides zinc oxide eugenol cement, a traditional material used in endodontic procedures for its sealing properties.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
jmoritausa.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
9494651051
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
021866033

Catalogue (35)

DeviceModel / ReferenceRegistriesClassStatus
Power Temp Cartridge Kit 2741000
FDA UDI
Class IActive
J. Morita Disposable Needle 25G-30mm 2025GL
FDA UDI
Class IActive
J. Morita Disposable Needle 30G-21mm 2030GS
FDA UDI
Class IActive
Perfectim Final Wash 21300800
FDA UDI
Class IIActive
J. Morita Disposable Needle 27G-30mm 2027GL
FDA UDI
Class IActive
Perfectim 90 Second Flexi-Velvet 21300650
FDA UDI
Class IIActive
Perfectim 90 Second Blue Velvet 21300550
FDA UDI
Class IIActive
J. Morita Disposable Needle 30G-25mm 2030GL
FDA UDI
Class IActive
Free Access II Cheek Retractor Small 21303100S
FDA UDI
Class IActive
Perfectim 30 Second Blue Velvet 21300500
FDA UDI
Class IIActive
CB Temp A3 28600200
FDA UDI
N/AUnknown
Power Temp Mini Syringe Kit 28800100
FDA UDI
Class IActive
CF Carbon Fiber Post Kit 23100550
FDA UDI
Class IActive
Silk Line Kit 28100100
FDA UDI
Class IIActive
Free Access II Cheek Retractor Small 21303100S
FDA UDI
Class IActive
Perfectim 30 Second SnoWhite 21300925
FDA UDI
Class IIActive
Perfectim 30 Second Flexi-Velvet 21300625
FDA UDI
Class IIActive
Free Access II Cheek Retractor Large 21303100L
FDA UDI
Class IActive
Perfectim Putty Type Kit 21300050
FDA UDI
Class IIActive
Silk Line Varnish Base Silk Line Varnish Base
FDA UDI
Class IIUnknown
Perfectim Tissue Mimic 21301100
FDA UDI
Class IIUnknown
FormCore DC 28700100
FDA UDI
Class IIActive
Perfectim Single Phase Body 21300700
FDA UDI
Class IIActive
Max Bond LC Agent A 28200200
FDA UDI
Class IIActive
CB Temp A2 28600100
FDA UDI
N/AActive
Silk Line Primer 28100300
FDA UDI
Class IIActive
J. Morita Disposable Needle 27G-21mm 2027GS
FDA UDI
Class IActive
Silk Line Varnish Catalyst Silk Line Varnish Catalyst
FDA UDI
Class IIUnknown
Max Bond LC Agent B 28200300
FDA UDI
Class IIActive
GF Glass Fiber Post Kit 23100580
FDA UDI
Class IActive
Free Access II Cheek Retractor Large 21303100L
FDA UDI
Class IActive
Silk Line Refill Cartridge 28100200
FDA UDI
Class IIActive
Rotary Master Plus 165350000
FDA UDI
Class IActive
Max Bond LC Kit 28200100
FDA UDI
Class IIActive
Perfectim 90 Second SnoWhite 21300950
FDA UDI
Class IIActive

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