TriActive Dental Implant System— 510(k) K261392
Substantially EquivalentParagon Implant Mfg., LLC
FDA 510(k) clearance K261392 for TriActive Dental Implant System, Substantially Equivalent on 2026-09-17. Applicant: Paragon Implant Mfg., LLC. Device class: 2.
Summary
TriActive Dental Implant System comes from Paragon Implant Mfg., LLC under product code DZE (Implant, Endosseous, Root-Form). The record doesn't list implant sizes or components.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as an Abbreviated 510(k). The decision was Substantially Equivalent.
Paragon filed from Calabasas, California. The decision came 141 calendar days after FDA received it (April 29 to September 17, 2026).
Clearance details
- Applicant
- Paragon Implant Mfg., LLC
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Calabasas, CA, US
Recent devices under product code DZE
view allMore clearances from Paragon Implant Mfg., LLC
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.