Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.
Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co. (Washington): 510(k) cleared for FDC Technology Industry Co. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 34 days ago, it serves as a historical benchmark. Score 61/100. 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: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 16 related WA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260029 |
| Device | Firstar Dental Handpieces |
| Applicant | FDC Technology Industry Co. |
| Specialty / panel | Dental |
| Product code | EFB |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-05 |
| Decision date | 2026-10-01 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Kent, WA, US |
| amount percentile | 93th of 414 (median 138, 1.9x 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: 2026-10-01
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (WA first): Firstar Dental Electric Motor (K260027) · EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti S · Class I recall Z-0127-2027 · Class I recall Z-0132-2027 · Class I recall Z-0131-2027 · Browse all by state and category →
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: Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co. and 17 Washington peers
- Washington FDAPulse records like this one: 17
- Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.'s amount: 93rd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Washington peer: $3,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 34 days ago.
What is the FDAPulse record for Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co. in Washington?
Firstar Dental Handpieces (K260029) by FDC Technology Industry Co. was cleared on 2026-10-01 after 269 days of review.
How does Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co. compare to other Washington FDAPulse records?
This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 34 days old, still within a typical 45-day follow-up window.
Firstar Dental Handpieces (K260029) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Firstar Dental Handpieces (K260029) | WA | 2026-10-01 |
| LuxDesign (K260421) | IL | 2026-10-23 |
| Mobile Dental Solution (Model | CN | 2026-10-23 |
| Forza (K260136) | CA | 2026-10-06 |
Compare Firstar Dental Handpieces (K260029) vs Firstar Dental Electric Motor (K260027) →
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