Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254152

Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International

Q: How to monitor Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International and peer dental records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International: 510(k) cleared for DiaDent Group International. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 50 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median

Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K254152
Device	Dia-X Sil Light Body
Applicant	DiaDent Group International
Specialty / panel	Dental
Product code	ELW
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-12-22
Decision date	2026-09-16
Review time (days)	268
Third-party review	No
Applicant location	Cheongju-Si, KR
amount percentile	90th of 414 (median 138, 1.9x median)
Peer records CSV (32 KR records)	🔒 Click to unlock →
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-16
Data refreshed: 2026-11-04
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Top FDAPulse records (KR first): cCeLL405 (K254030) · ECG Analysis Software (AiTiALVSD) (K254302) · REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) · S-Patch CardioAI (K254255) · PicoreMax (PicoreMax) (K254199) · 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: Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International and 32 KR peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

KR FDAPulse records like this one: 32
Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International's amount: 90th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

55 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.

What is the FDAPulse record for Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International?

Dia-X Sil Light Body (K254152) by DiaDent Group International was cleared on 2026-09-16 after 268 days of review.

How does Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International compare to other FDAPulse records?

This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 50 days old; check the official source for later updates before acting.

Dia-X Sil Light Body (K254152) vs. top 2 peers

Organization	Location	Record date	Compare
Dia-X Sil Light Body (K254152)	KR	2026-09-16	This record
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210)	KR	2026-09-25	View record →
Dia-X Sil Heavy Body (K254142)	KR	2026-09-16	Compare Dia-X Sil Light Body (K254152) vs Dia-X Sil Heavy Body (K254142) →

How to monitor Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International and peer dental records

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