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Sign in to claim this brandJMU DENTAL, INC
US
Last updated September 17, 2026
What JMU DENTAL, INC makes
JMU Dental, Inc. manufactures reusable and single-use dental instruments, including diamond and carbide burs for cutting and shaping teeth, rotary and manual endodontic files for root canal treatment, and nitrile examination gloves for sterile procedures. The company also supplies natural gutta-percha for dental filling materials and single-use isolation gowns for patient protection during treatments.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 JMU Dental, Inc. manufacture?
JMU Dental, Inc. specializes in dental devices, producing both reusable and single-use products. Their portfolio includes diamond and carbide dental burs for tooth preparation, rotary and manual endodontic files/rasps for root canal procedures, nitrile examination gloves for sterile procedures, natural gutta-percha for dental fillings, and single-use isolation gowns for patient protection. These devices are designed to support various stages of dental treatment.
Where is JMU Dental, Inc. based, and what does that mean for their regulatory compliance?
JMU Dental, Inc. is based in the United States, meaning their devices are subject to FDA regulations. The company’s products fall under Class I and Class II classifications, which require compliance with FDA requirements for safety and performance. Since they are listed in the FDA’s Unique Device Identifier (UDI) database, their devices are tracked for transparency and traceability within the U.S. regulatory system.
Which regulatory registries or databases list JMU Dental, Inc.’s devices?
JMU Dental, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, reporting, and compliance purposes, helping healthcare providers and regulators verify device details. The UDI system is a key part of the FDA’s efforts to improve transparency and safety in medical device distribution.
How are JMU Dental, Inc.’s devices classified under FDA regulations?
JMU Dental, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks, as outlined in FDA guidelines.
Why do some of JMU Dental, Inc.’s devices require special controls, while others do not?
The distinction between Class I and Class II devices depends on the level of risk associated with each product. For example, reusable dental burs and manual endodontic files may be classified as Class II because they involve precision tools used in critical procedures like root canal therapy, requiring additional validation for safety and performance. In contrast, nitrile gloves and isolation gowns—while essential—are typically lower risk and may fall under Class I, relying primarily on general manufacturing and labeling controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 150 E Lambert Rd, Fullerton, CA, 92835
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3014683120
- DUNS Number
- 081258380
Catalogue (691)
Page 4 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Jmu | 21602008 | FDA UDI | Class I | Active |
| Jmu | 19701064 | FDA UDI | Class I | Active |
| Jmu | 25301063 | FDA UDI | Class I | Active |
| Jmu | 21602004 | FDA UDI | Class I | Active |
| Jmu | 19701061 | FDA UDI | Class I | Active |
| Jmu | 25405012 | FDA UDI | Class I | Active |
| Jmu | 25301027 | FDA UDI | Class I | Active |
| Jmu | 14001005 | FDA UDI | Class I | Active |
| Jmu | 25407003 | FDA UDI | Class I | Active |
| Jmu | 13004002 | FDA UDI | Class II | Active |
| Jmu | 14508002 | FDA UDI | Class I | Active |
| Jmu | 21518027 | FDA UDI | Class I | Active |
| Jmu | 21517029 | FDA UDI | Class I | Active |
| Jmu | 19701046 | FDA UDI | Class I | Active |
| Jmu | 22801032 | FDA UDI | Class I | Active |
| Jmu | 25407004 | FDA UDI | Class I | Active |
| Jmu | 22405007 | FDA UDI | Class I | Active |
| Jmu | 36106002 | FDA UDI | Class I | Active |
| Jmu | 21518033 | FDA UDI | Class I | Active |
| Jmu | 21518004 | FDA UDI | Class I | Active |
| Jmu | 24001005 | FDA UDI | Class II | Active |
| Jmu | 19701007 | FDA UDI | Class I | Active |
| Jmu | 19701049 | FDA UDI | Class I | Active |
| Jmu | 25301024 | FDA UDI | Class I | Active |
| Jmu | 21518022 | FDA UDI | Class I | Active |
| Jmu | 32101018 | FDA UDI | Class II | Active |
| Jmu | 24007002 | FDA UDI | Class II | Active |
| Jmu | 19701036 | FDA UDI | Class I | Active |
| Jmu | 22801044 | FDA UDI | Class I | Active |
| Jmu | 14001008 | FDA UDI | Class I | Active |
| Jmu | 22801029 | FDA UDI | Class I | Active |
| Jmu | 14001016 | FDA UDI | Class I | Active |
| Jmu | 19701020 | FDA UDI | Class I | Active |
| Jmu | 25301076 | FDA UDI | Class I | Active |
| Jmu | 13901001 | FDA UDI | Class I | Active |
| Jmu | 22801027 | FDA UDI | Class I | Active |
| Jmu | 25301018 | FDA UDI | Class I | Active |
| Jmu | 14508001 | FDA UDI | Class I | Active |
| Jmu | 25301077 | FDA UDI | Class I | Active |
| Jmu | 25301042 | FDA UDI | Class I | Active |
| Jmu | 36106003 | FDA UDI | Class I | Active |
| Jmu | 21602007 | FDA UDI | Class I | Active |
| Jmu | 13004001 | FDA UDI | Class II | Active |
| Jmu | 25405013 | FDA UDI | Class I | Active |
| Jmu | 25301009 | FDA UDI | Class I | Active |
| Jmu | 14001010 | FDA UDI | Class I | Active |
| Jmu | 19701016 | FDA UDI | Class I | Active |
| Jmu | 22801046 | FDA UDI | Class I | Active |
| Jmu | 14508008 | FDA UDI | Class I | Active |
| Jmu | 19701036 | FDA UDI | Class I | Active |
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