FDA 510(k) K261392: TriActive Dental Implant System
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental implant practices and specialists can now consider a new Class II endosseous root-form implant option that has cleared FDA review, potentially adding a vendor choice without altering existing regulatory obligations.
Key points
- Product: TriActive Dental Implant System (Paragon Implant Mfg., LLC), 510(k) K261392, classified under regulation 872.3640 with product code DZE.
- Clearance pathway: Abbreviated 510(k) review, determined substantially equivalent to predicate devices.
- Device class remains Class 2, so standard implant labeling, sterilization, and adverse-event reporting rules apply.
- No novel clinical indications or unique material composition are stated, so practices should evaluate on usual criteria (price, geometry, surface, service).
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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