TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC
TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC (California): 510(k) cleared for Paragon Implant Mfg., LLC. Its amount of 141 is above the median of 138 (52nd percentile). Dated 48 days ago, it serves as a historical benchmark. Score 35/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 141 · 52th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261392 |
| Device | TriActive Dental Implant System |
| Applicant | Paragon Implant Mfg., LLC |
| Specialty / panel | Dental |
| Product code | DZE |
| Device class | 2 |
| Clearance type | Abbreviated |
| Decision | Substantially Equivalent |
| Received | 2026-04-29 |
| Decision date | 2026-09-17 |
| Review time (days) | 141 |
| Third-party review | No |
| Applicant location | Calabasas, CA, US |
| amount percentile | 52th of 414 (median 138, 1.0x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-17
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC and 76 California peers
- California FDAPulse records like this one: 76
- TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC's amount: 52nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 141-day review: this device is a strong predicate for similar products.
- Abbreviated 510(k): a modification of an existing device.
What is the FDAPulse record for TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC in California?
TriActive Dental Implant System (K261392) by Paragon Implant Mfg., LLC was cleared on 2026-09-17 after 141 days of review.
How does TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC compare to other California FDAPulse records?
Its amount of 141 sits in the upper half (52th percentile) of 414 records; the median is 138. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
TriActive Dental Implant System (K261392) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TriActive Dental Implant System (K261392) | CA | 2026-09-17 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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