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Is Passivity Plus™ safe, FDA cleared, and easy to maintain?

Yes. Passivity Plus™ is FDA cleared, designed to minimize contamination risk, and requires no special cleaning or maintenance protocols beyond what clinicians already use for conventional implant-supported prostheses.

Regulatory Status

Passivity Plus™ is FDA 510(k) cleared as a Class II dental prosthetic component under the name Nikolas Base. The product has maintained FDA listing, with reference numbers currently being updated through the standard Letter to File process. Roedentallab

Leakage and Contamination Risk

No significant risks are anticipated based on the product design. The adjustable interface involves micro-scale movements (microns, less than 2°), far less than depicted in educational animations. Components press tightly together when torqued, minimizing any potential gap. All connection surfaces are polished titanium, and the assembly seats against tissue with compression. Formal testing is planned to document safety. Clinical cases to date have not shown contamination issues. RoedentallabRoedentallab

Long-Term Cleaning and Maintenance

Passivity Plus™ requires no special hygiene protocols. Restorations can be treated exactly like conventional implant-supported prostheses, with no added instruments or procedures.

Safety and Maintenance at a Glance

Category Detail
FDA status 510(k) cleared, Class II dental prosthetic component (Nikolas Base)
Leakage risk Minimal; micron-scale interface movements and torqued compression create a tight seal
Contamination No issues reported in clinical cases; formal testing planned
Interface surfaces Polished titanium, tight-fitting
Routine cleaning Standard prosthesis hygiene protocols
Professional maintenance Per clinician's standard recall schedule
Between-component cleaning Not required
Special instruments None

Bottom Line

Passivity Plus™ meets FDA Class II clearance standards, presents no anticipated leakage or contamination concerns due to its tight titanium interface and micron-scale adjustments, and integrates into existing hygiene and recall workflows without adding new steps for clinicians or patients.

Additional Resources

For more information concerning Passivity Plus:

 

Contact Information

For help implementing Passivity Plus to your next case, contact ROE Dental Laboratory: