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US
Last updated May 27, 2026
What ORIKAM HEALTHCARE INDIA PRIVATE LIMITED makes
The company manufactures reusable rotary and reciprocating endodontic files and rasps designed for dental procedures, including single-file systems like the Neoendo S and MyEndo T, as well as specialized sets for retreatment, pediatric use, and canal preparation. Additional products include glide path files (e.g., Neoendo Neoglide, MyEndo GLIDE), tapered shaping files (Neoendo Neotaper), and hybrid instruments (Neoendo Neohybrid) for precise root canal instrumentation.
These devices are classified as Class I under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable domestic and international standards for endodontic instrumentation.
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 Orikam Healthcare India Private Limited manufacture?
Orikam Healthcare India Private Limited specializes in reusable rotary and reciprocating endodontic files and rasps. These devices are primarily used in dental procedures to prepare root canals, including single-file systems like the Neoendo S and MyEndo T, as well as specialized sets for retreatment, pediatric use, and canal shaping. Examples include glide path files (e.g., Neoendo Neoglide), tapered shaping files (Neoendo Neotaper), and hybrid instruments (Neoendo Neohybrid) for precise root canal treatment.
Where is Orikam Healthcare India Private Limited based?
Orikam Healthcare India Private Limited is based in the United States. The company operates from there while adhering to applicable domestic and international standards for the manufacturing and distribution of its endodontic instrumentation.
Which regulatory registries or databases list Orikam Healthcare India Private Limited’s devices?
Orikam Healthcare India Private Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Orikam Healthcare India Private Limited’s devices classified under regulatory frameworks?
Orikam Healthcare India Private Limited’s endodontic files and rasps are classified as Class I devices. This classification is typically assigned to low-risk medical devices, such as reusable dental instruments, where the risk to patients is minimal and the regulatory oversight is streamlined. Classification is determined by factors like intended use, duration of contact with the patient, and potential risks.
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
- 644871383
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neoendo S | NSF0403 | FDA UDI | Class I | Active |
| MyEndo T | MET0418 | FDA UDI | Class I | Active |
| Neoendo Flex Files | NFF0401 | FDA UDI | Class I | Active |
| Neoendo Retreatment File | NRF0404 | FDA UDI | Class I | Active |
| Neoendo Neoglide | NGL0414 | FDA UDI | Class I | Active |
| Neoendo Neotaper | NNT0415 | FDA UDI | Class I | Active |
| MyEndo GLIDE | MEG0419 | FDA UDI | Class I | Active |
| Neoendo Pedoflex | NPF0405 | FDA UDI | Class I | Active |
| Neoendo Neohybrid | NHF0402 | FDA UDI | Class I | Active |
| Neoendo Flex Glide | NFG0407 | FDA UDI | Class I | Active |
| Neoendo Neoblue | NBF0416 | FDA UDI | Class I | Active |
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