# Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co.

**Predicate Speed & CAPA Advisory Opportunity Score:** 61/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260027 |
| Device | Firstar Dental Electric Motor |
| Applicant | FDC Technology Industry Co. |
| Specialty / panel | Dental |
| Product code | EBW |
| 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 |

## Why this score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 35 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260027). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.