iSy Implant System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by ALTATEC GmbH
Identifiers
- 510(k) Number
- K151599 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iSy Implant System is a dental implant device designed for osseointegrated restoration in the oral cavity. It is classified under dental implant systems and is intended for use in reconstructive procedures to support prosthetic teeth, providing stable and long-term fixation in the jawbone.
The system is supplied sterile and intended for single-use, adhering to dental implant workflows with a simplified drilling protocol. It includes a single-patient form drill and offers modular components such as a pre-mounted implant base or snap-in insertion post. Authorized under FDA 510K clearance (K151599) and MDR compliance, it is manufactured in Germany by Altatec GmbH.
Frequently asked questions
What types of dental procedures is the iSy Implant System designed to support, and how does it simplify the workflow for clinicians?
The iSy Implant System is specifically designed for osseointegrated dental restoration in the oral cavity, providing stable fixation for prosthetic teeth during reconstructive procedures. It simplifies the workflow by including a single-patient form drill, which reduces the need for multiple tools, and modular components like a pre-mounted implant base or snap-in insertion post, streamlining the implant placement process.
Is the iSy Implant System intended for reuse, or is it meant to be used only once per patient? How does this affect its sterility?
The iSy Implant System is explicitly intended for single-use per patient, aligning with standard dental implant workflows. This design ensures sterility is maintained, as it is supplied sterile and avoids the risks associated with reprocessing or reuse, which could compromise patient safety.
What regulatory pathways has the iSy Implant System undergone, and where is it manufactured?
The iSy Implant System has been authorized through both FDA 510(k) clearance (K151599) and MDR compliance, meeting stringent regulatory standards for dental implants. It is manufactured in Germany by Altatec GmbH, ensuring adherence to European and U.S. medical device regulations.
Does the iSy Implant System come with any specific modular components, and how might these benefit a clinician during an implant procedure?
Yes, the iSy Implant System includes modular components such as a pre-mounted implant base and a snap-in insertion post. These features allow clinicians to customize the implant placement process, reducing preparation time and improving precision during prosthetic attachment, which can enhance patient outcomes.
What is the primary advantage of using the single-patient form drill included with the iSy Implant System?
The single-patient form drill in the iSy Implant System is designed to minimize cross-contamination risks by eliminating the need to reuse tools across multiple patients. This aligns with single-use protocols, ensuring a sterile field for each procedure and reducing the complexity of sterilization steps in the dental office.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALTATEC GmbH - Zahnimplantate Hersteller Camlog, iSy implant system by Camlog - the ideal second system, Altatec Produkte - Camlog Implantate Qualität Made in Germany
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151599 | Class II | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (2)
- FDA 510(k) K151599 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026