DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.: 510(k) cleared for SETAGAYA SEIKI Co., Ltd. Its amount of 90 is below the median of 138 (31st percentile). Dated 43 days ago, it serves as a historical benchmark. Score 36/100. 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: 90 · 31th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262144 |
| Device | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece |
| Applicant | SETAGAYA SEIKI Co., Ltd. |
| Specialty / panel | Dental |
| Product code | EFB |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-09-23 |
| Review time (days) | 90 |
| Third-party review | No |
| Applicant location | Yonezawa-City, JP |
| amount percentile | 31th of 414 (median 138, 0.7x median) |
| Peer records CSV (10 JP records) | 🔒 Click to unlock → |
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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: 2026-09-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (JP first): Lilium one (USM330) (K260605) · SCENARIA View Phase 6.0 (K261229) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · TSK OptiXion (K262516) · Browse all by state and category →
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: DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd. and 10 JP peers
- JP FDAPulse records like this one: 10
- DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.'s amount: 31st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 90-day review: this device is a strong predicate for similar products.
- Posted 43 days ago.
What is the FDAPulse record for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.?
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144) by SETAGAYA SEIKI Co., Ltd. was cleared on 2026-09-23 after 90 days of review.
How does DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd. compare to other FDAPulse records?
Its amount of 90 is below the median (31th percentile); smaller records often move faster and face less competition. It is 43 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144) | JP | 2026-09-23 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
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