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=K262982

Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.

Q: How to monitor Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd. 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.

Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.: 510(k) cleared for Spident Co., Ltd. Its amount of 25 is below the median of 138 (2nd percentile). Dated 45 days ago, it serves as a historical benchmark. Score 41/100. 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: 25 · 2th percentile of 414 FDAPulse records · 0.2x 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	K262982
Device	Core·it Dual
Applicant	Spident Co., Ltd.
Specialty / panel	Dental
Product code	EBF
Device class	2
Clearance type	Special
Decision	Substantially Equivalent
Received	2026-08-27
Decision date	2026-09-21
Review time (days)	25
Third-party review	No
Applicant location	Incheon, KR
amount percentile	2th of 414 (median 138, 0.2x 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: 2026-09-21
Data refreshed: 2026-11-04
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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: Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd. and 32 KR peers

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

KR FDAPulse records like this one: 32
Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.'s amount: 2nd 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)

41 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Fast 25-day review: this device is a strong predicate for similar products.
Special 510(k): a modification of an existing device.
Posted 45 days ago.

What is the FDAPulse record for Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.?

Core·it Dual (K262982) by Spident Co., Ltd. was cleared on 2026-09-21 after 25 days of review.

How does Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd. compare to other FDAPulse records?

Its amount of 25 is below the median (2th percentile); smaller records often move faster and face less competition. It is 45 days old, still within a typical 45-day follow-up window.

Core·it Dual (K262982) vs. top 3 peers

Organization	Location	Record date
Core·it Dual (K262982)	KR	2026-09-21
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210)	KR	2026-09-25
Dia-X Sil Light Body (K254152)	KR	2026-09-16
Dia-X Sil Heavy Body (K254142)	KR	2026-09-16

How to monitor Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd. and peer dental records

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