Identifiers
- 510(k) Number
- K091252 FDA 510(k)
- FDA Product Code
- DZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Implant Center 2 is a powered dental drill designed for bone preparation in dental implantology. Classified as a Drill, Bone, Powered, it is intended for use in surgical procedures requiring precise bone drilling and shaping to accommodate dental implants. This device is engineered to provide controlled cutting and removal of bone tissue, facilitating optimal implant placement in various dental applications.
The Implant Center 2 is supplied as a reusable dental instrument, intended for use in clinical settings such as dental offices and oral surgery centers. It operates with interchangeable handpieces and accessories, including perforators and extraction tools, and is compatible with autoclave sterilization for repeated use. The device is classified under regulation number 872.4120 and holds an FDA 510K clearance for dental use. No specific MRI safety information is provided, and its operation requires adherence to standard dental infection control protocols.
Frequently asked questions
What is the Implant Center 2 used for in dental implantology?
The Implant Center 2 is a powered dental drill designed specifically for bone preparation during dental implant procedures. It enables precise cutting and shaping of bone tissue to create optimal sites for implant placement, ensuring accurate and controlled bone removal in various dental applications.
Is the Implant Center 2 a single-use or reusable device?
The Implant Center 2 is a reusable dental instrument. It is built for repeated clinical use in settings like dental offices and oral surgery centers, with the added benefit of compatibility with autoclave sterilization to maintain sterility between procedures.
What types of accessories are compatible with the Implant Center 2?
The Implant Center 2 operates with interchangeable handpieces and accessories, including perforators and extraction tools. These accessories allow clinicians to adapt the device for different surgical tasks, such as precise bone drilling or tissue removal, depending on the specific requirements of the procedure.
How should the Implant Center 2 be stored and maintained?
Since the Implant Center 2 is reusable and designed for autoclave sterilization, proper storage involves keeping it in a clean, dry environment when not in use. After each procedure, it must undergo sterilization to ensure infection control compliance. Follow manufacturer guidelines for maintenance to preserve functionality and longevity.
Does the Implant Center 2 have any specific MRI safety information?
The device documentation does not provide explicit MRI safety information for the Implant Center 2. Clinicians should exercise caution and consult the manufacturer’s guidelines if MRI compatibility is required for any associated components or accessories used with this device.
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: SATELEC IMPLANT CENTER 2 USER MANUAL Pdf Download, Implantcenter 2 (Acteon/Satelec) - Pearson Dental, Satelec Implant Center 2 User Manual - Download & Read Online | Manualzz, Satelec Implant Center 2 Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091252 | Class II | Active |
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Manufacturer
- Manufacturer
- Satelec
Sources (1)
- FDA 510(k) K091252 24 fields · synced Oct 1, 2026