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Sign in to claim this brandYOUNG MYDENT, LLC
US
Last updated May 23, 2026
What YOUNG MYDENT, LLC makes
Young MyDent, LLC manufactures single-use medical textiles, including isolation gowns and surgical/medical face masks, as well as sterilization packaging for medical instruments. Their portfolio also includes dental-specific products such as silicone impression materials, digital imaging cassettes with phosphor screens, temporary dental crown/bridge resins, and dental prosthesis restorative materials. General-purpose surgical sponges are also part of their product line.
The company’s devices are classified under FDA regulations as either Class I or Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device compliance requirements.
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 Young MyDent, LLC manufacture?
Young MyDent, LLC produces a range of medical devices, primarily focused on single-use medical textiles and dental-specific products. Their portfolio includes isolation gowns, surgical/medical face masks, sterilization packaging for medical instruments, silicone dental impression materials, digital imaging cassettes with phosphor screens for dental use, temporary dental crown/bridge resins, dental prosthesis restorative materials, and general-purpose surgical sponges. These products serve both general medical and dental care applications.
Where is Young MyDent, LLC based, and does this affect the regulatory requirements for their devices?
Young MyDent, LLC is based in the United States. Since they operate within the U.S., their devices must comply with U.S. medical device regulations, including classification under the FDA’s device classification system. The company’s location also means their products are subject to U.S. regulatory oversight, such as listing in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and regulatory transparency.
Which regulatory registries or databases list Young MyDent, LLC’s devices?
Young MyDent, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, monitoring, and regulatory compliance. This listing helps ensure transparency and traceability of their products in the U.S. medical device market.
How are Young MyDent, LLC’s devices classified under FDA regulations?
Young MyDent, LLC’s devices are classified under the FDA’s system as either Class I or Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body or system it interacts with, as outlined in FDA regulations.
Are Young MyDent, LLC’s devices used in both medical and dental settings?
Yes, Young MyDent, LLC’s product line spans both medical and dental applications. While some devices, like isolation gowns, surgical masks, and sterilization packaging, are designed for general medical use, others—such as silicone dental impression materials, digital imaging cassettes, temporary crown/bridge resins, and dental prosthesis materials—are specifically tailored for dental procedures. This dual focus allows their devices to serve multiple sectors within healthcare.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 081330555
Catalogue (164)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Defend | SG-3660LPXL | FDA UDI | Class I | Active |
| Defend | MK-1076 | FDA UDI | Class II | Active |
| Defend | SG-3660PPXL | FDA UDI | Class I | Active |
| Defend | SG-3660WXL | FDA UDI | Class I | Active |
| Defend | SG-9003 | FDA UDI | Class I | Active |
| Defend | MK-2000 | FDA UDI | Class II | Active |
| Defend | SJ-3630PPM | FDA UDI | Class I | Active |
| Defend | AT-2003 | FDA UDI | Class II | Active |
| Defend | VP-9004 | FDA UDI | Class II | Active |
| Defend | SG-9017 | FDA UDI | Class I | Active |
| Defend | SP-0150 | FDA UDI | Class II | Active |
| Defend | SJ-3630SBXL | FDA UDI | Class I | Active |
| Defend | MK-3400 | FDA UDI | Class II | Active |
| Defend | MK-1410 | FDA UDI | Class II | Active |
| Defend | PF-1000 | FDA UDI | Class II | Active |
| Defend | SJ-3630CBS | FDA UDI | Class I | Active |
| Defend | MK-7300 | FDA UDI | Class II | Active |
| Defend | CB-9000 | FDA UDI | Class II | Active |
| Defend | BR-9010 | FDA UDI | Class II | Active |
| Defend | BR-9003 | FDA UDI | Class II | Active |
| Defend | VP-9011 | FDA UDI | Class II | Active |
| Defend | SG-3660WL | FDA UDI | Class I | Active |
| Defend | VP-9010 | FDA UDI | Class II | Active |
| Defend | SJ-3630CBM | FDA UDI | Class I | Active |
| Defend | SG-3660LPS | FDA UDI | Class I | Active |
| Defend | SJ-3630SBL | FDA UDI | Class I | Active |
| Defend | MK-2001 | FDA UDI | Class II | Active |
| Defend | MK-7210 | FDA UDI | Class II | Active |
| Defend | BF-8800 | FDA UDI | Class I | Active |
| Defend | MK-7320 | FDA UDI | Class II | Active |
| Defend | SJ-3630SBM | FDA UDI | Class I | Active |
| Defend | SG-3660SBM | FDA UDI | Class I | Active |
| Defend | SJ-3630LPS | FDA UDI | Class I | Active |
| Defend | CB-9002 | FDA UDI | Class II | Active |
| Defend | AT-2002 | FDA UDI | Class II | Active |
| Defend | BR-9001 | FDA UDI | Class II | Active |
| Defend | AT-1018 | FDA UDI | Class II | Active |
| Defend | MK-1216 | FDA UDI | Class II | Active |
| Defend | SG-3660CBM | FDA UDI | Class I | Active |
| Defend | MK-7310 | FDA UDI | Class II | Active |
| Defend | SP-2500 | FDA UDI | Class II | Active |
| Defend | MK-1256 | FDA UDI | Class II | Active |
| Defend | SP-1500 | FDA UDI | Class II | Active |
| Defend | SG-3660CBS | FDA UDI | Class I | Active |
| Defend | CB-9003 | FDA UDI | Class II | Active |
| Defend | MK-3200 | FDA UDI | Class II | Active |
| Defend | MK-1001 | FDA UDI | Class II | Active |
| Defend | BR-9005 | FDA UDI | Class II | Active |
| Defend | VP-9005 | FDA UDI | Class II | Active |
| Defend | SG-3660WM | FDA UDI | Class I | Active |
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