MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd.
MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. (Illinois): 510(k) cleared for Alpha Bio Tec , Ltd. Its amount of 185 is above the median of 138 (65th percentile). Dated 14 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-04, 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: 185 · 65th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261295 |
| Device | MultiNeO Dental Implant System |
| Applicant | Alpha Bio Tec , Ltd. |
| Specialty / panel | Dental |
| Product code | DZE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-20 |
| Decision date | 2026-10-22 |
| Review time (days) | 185 |
| Third-party review | No |
| Applicant location | Modi'In, IL |
| amount percentile | 65th of 414 (median 138, 1.3x 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: 2026-10-22
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd.'s amount: 65th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 185-day review, longer than typical.
- Posted 14 days ago.
What is the FDAPulse record for MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. in Illinois?
MultiNeO Dental Implant System (K261295) by Alpha Bio Tec , Ltd. was cleared on 2026-10-22 after 185 days of review.
How does MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. compare to other Illinois FDAPulse records?
Its amount of 185 sits in the upper half (65th percentile) of 414 records; the median is 138. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
MultiNeO Dental Implant System (K261295) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MultiNeO Dental Implant System (K261295) | IL | 2026-10-22 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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