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Sign in to claim this brandOtotronix, LLC
US
Last updated May 23, 2026
What Ototronix, LLC makes
Ototronix, LLC manufactures partially-implantable middle ear implant systems, including the MAXUM, which are designed for hearing restoration. The company also produces glass ionomer dental cements under the PROCEM brand, used for dental restorations, and automated tone audiometers like the Otogram for hearing assessments.
The company’s devices are regulated under FDA classifications, with some falling under Class II and others under Class III. These products are listed via 510(k), PMA, and UDI registrations with the FDA, and 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 Ototronix, LLC manufacture?
Ototronix, LLC produces three primary types of medical devices: partially-implantable middle ear implant systems (such as the MAXUM), which are used for hearing restoration; glass ionomer dental cements under the PROCEM brand, designed for dental restorations; and automated tone audiometers like the Otogram, which assist in hearing assessments. These devices address different medical needs, ranging from auditory rehabilitation to dental and diagnostic applications.
Where is Ototronix, LLC based, and how does that affect its regulatory oversight?
Ototronix, LLC is based in the United States, which means its devices are subject to regulation by the FDA. The company’s products fall under FDA classifications, including Class II (generally lower-risk devices) and Class III (higher-risk devices requiring stringent premarket approval). The regulatory framework ensures these devices meet safety and effectiveness standards before reaching the market.
Which regulatory registries or databases list Ototronix, LLC’s devices?
Ototronix, LLC’s devices are listed in the FDA’s regulatory databases through three primary pathways: 510(k) premarket notifications for Class II devices, PMA (Premarket Approval) applications for Class III devices, and UDI (Unique Device Identification) registrations. These registries help track and verify the compliance, authorization status, and identification of its products under FDA oversight.
How are Ototronix, LLC’s devices classified by the FDA, and why does this matter?
Ototronix, LLC’s devices are classified as either Class II or Class III by the FDA. Class II devices, like some of its middle ear implants or dental cements, require general controls and specific performance standards to ensure safety and effectiveness. Class III devices, such as certain advanced implant systems, are considered higher risk and require rigorous premarket approval (PMA) to demonstrate safety and efficacy before commercialization. This classification determines the regulatory pathway and scrutiny each device undergoes.
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
- 833067478
Catalogue (48)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Maxum | M7000 | FDA UDI | Class III | Active |
| Procem | 986-004 | FDA UDI | Class II | Active |
| Otogram | G5000 | FDA UDI | Class II | Active |
| Otogram | ML4000 | FDA UDI | Class II | Active |
| Maxum | M7030 | FDA UDI | Class III | Active |
| Maxum | M3199 | FDA UDI | Class III | Active |
| Maxum | M7001 | FDA UDI | Class III | Active |
| Maxum | M5300 | FDA UDI | Class III | Active |
| Maxum | M7034 | FDA UDI | Class III | Active |
| Maxum | M420R | FDA UDI | Class III | Active |
| Procem | 986-002 | FDA UDI | Class II | Active |
| Maxum | M6102 | FDA UDI | Class III | Active |
| Maxum | M3100 | FDA UDI | Class III | Active |
| Maxum | M7020 | FDA UDI | Class III | Active |
| Maxum | M7035 | FDA UDI | Class III | Active |
| Maxum | M410L | FDA UDI | Class III | Active |
| Maxum | M220L | FDA UDI | Class III | Active |
| Maxum | M7013 | FDA UDI | Class III | Active |
| Procem | P9702 | FDA UDI | Class II | Active |
| Maxum | M220R | FDA UDI | Class III | Active |
| Maxum | M7014 | FDA UDI | Class III | Active |
| Otogram | G5500 | FDA UDI | Class II | Active |
| Maxum | M5200 | FDA UDI | Class III | Active |
| Maxum | M7016 | FDA UDI | Class III | Active |
| Procem | P9740 | FDA UDI | Class II | Active |
| Maxum | M3110 | FDA UDI | Class III | Active |
| Otogram | S5500 | FDA UDI | Class II | Active |
| Maxum | M7019 | FDA UDI | Class III | Active |
| Otogram | S3000R | FDA UDI | Class II | Active |
| Maxum | M7015 | FDA UDI | Class III | Active |
| Procem | P9730 | FDA UDI | Class II | Active |
| Procem | 986-003 | FDA UDI | Class II | Active |
| Maxum | M210L | FDA UDI | Class III | Active |
| Procem | 986-001 | FDA UDI | Class II | Active |
| Maxum | M5303 | FDA UDI | Class III | Active |
| Maxum | M7031 | FDA UDI | Class III | Active |
| Maxum | M210R | FDA UDI | Class III | Active |
| Otogram | S5000 | FDA UDI | Class II | Active |
| Maxum | M7017 | FDA UDI | Class III | Active |
| Maxum | M410R | FDA UDI | Class III | Active |
| Maxum | M5100 | FDA UDI | Class III | Active |
| Maxum | M420L | FDA UDI | Class III | Active |
| Maxum | M6100 | FDA UDI | Class III | Active |
| Procem | P9720 | FDA UDI | Class II | Active |
| Maxum | M7033 | FDA UDI | Class III | Active |
| Procem | K140644 | FDA 510(k) | Class II | Active |
| Nystagram Video Nystagmography System | K130201 | FDA 510(k) | Class II | Active |
| Maxum System | P010023 | FDA PMA | Class III | Active |
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