W&H Implantmed SI-1015 incl. Accessories
by W&H Dentalwerk Bürmoos GmbH EUDAMED510(k)
Active
510(k) K161957
Overview
The W&H Implantmed SI-1015 is a dental surgical unit designed for implantology procedures. It combines a controller, foot pedal, and handpiece to provide precise control over implant placement, featuring torque regulation and an automatic thread cutter for enhanced accuracy.
Supplied as a reusable system, the device is intended for use in dental clinics and surgical settings. It operates with non-sterile components for setup and sterile handpieces for patient contact, adhering to Class I medical device regulations (872.4200). Authorised under FDA 510(k) clearance and MDD compliance, the SI-1015 includes multiple FEI-coded accessories for compatibility with implant systems and diagnostic modules.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK161957 | Date23 Nov 2016 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- EBW
- FDA applicant
- W&H Dentalwerk Burmoos GmbH
- Device Class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from W&H Dentalwerk Bürmoos GmbH
Questions
What types of dental implant procedures is the W&H Implantmed SI-1015 designed to assist with, and how does it enhance precision during surgery?
The W&H Implantmed SI-1015 is specifically designed for dental implantology procedures, offering precise control over implant placement through torque regulation and an automatic thread cutter. This ensures accurate and consistent drilling, reducing human error and improving the fit of dental implants during surgery.
Is the W&H Implantmed SI-1015 system reusable, and if so, how should the reusable components be handled to maintain sterility during use?
Yes, the W&H Implantmed SI-1015 is supplied as a reusable system, featuring non-sterile components for setup (like the controller and foot pedal) and sterile handpieces for direct patient contact. To maintain sterility, sterile handpieces must be used for each patient, while the reusable controller and foot pedal should be cleaned and disinfected according to standard dental clinic protocols between uses.
What compatibility does the SI-1015 have with different dental implant systems, and how are these compatibilities indicated?
The W&H Implantmed SI-1015 includes multiple FEI-coded accessories designed for compatibility with various dental implant systems. These FEI codes (e.g., 3011649314, 3038718579) ensure the system can be tailored to specific implant brands or protocols, allowing clinicians to select the appropriate handpiece or attachment for their procedure.
How should the W&H Implantmed SI-1015 be stored to preserve its functionality and ensure longevity?
The reusable components of the SI-1015, such as the controller and foot pedal, should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Sterile handpieces should be stored in their original packaging or a sealed container until use, following manufacturer guidelines to prevent contamination or damage. Always refer to the included user manual for specific storage instructions.
What regulatory pathways has the W&H Implantmed SI-1015 followed, and what does this mean for clinicians using the device?
The W&H Implantmed SI-1015 has undergone FDA 510(k) clearance and complies with the Medical Devices Directive (MDD), confirming it meets Class I medical device standards (872.4200) for dental surgical units. This means clinicians can rely on its safety and performance for dental implant procedures, as it has been evaluated and authorized by relevant regulatory bodies for use in dental clinics and surgical settings.