# INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262980 |
| Device | INNI-CERA (BCM-W500, BCM-W1000) |
| Applicant | DentMedi Co., Ltd. |
| Specialty / panel | Dental |
| Product code | EIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-27 |
| Decision date | 2026-10-21 |
| Review time (days) | 55 |
| Third-party review | No |
| Applicant location | Gunposi, KR |

## Why this score
- Fast 55-day review: this device is a strong predicate for similar products.
- Posted 15 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=K262980). 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.