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Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International vs Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International: FDAPulse comparison
Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International's review days of 268 is 1.0x Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International's 268 (90th percentile). Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International is dated 2026-09-16; Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International 2026-09-16.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International compare to Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International?
| Field | Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International | Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254142 | K254152 |
| Device | Dia-X Sil Heavy Body | Dia-X Sil Light Body |
| Applicant | DiaDent Group International | DiaDent Group International |
| Specialty / panel | Dental | Dental |
| Product code | ELW | ELW |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-22 | 2025-12-22 |
| Decision date | 2026-09-16 | 2026-09-16 |
| Review time (days) | 268 | 268 |
| Third-party review | No | No |
| Applicant location | Cheongju-Si, KR | Cheongju-Si, KR |
| amount percentile | 90th | 90th |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 55/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International · Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International
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