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=K262983

EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.

Q: How to monitor EsTemp Implant (K262983): 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.

EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.: 510(k) cleared for Spident Co., Ltd. Its amount of 29 is below the median of 138 (7th percentile). Dated 40 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 29 · 7th 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	K262983
Device	EsTemp Implant
Applicant	Spident Co., Ltd.
Specialty / panel	Dental
Product code	EMA
Device class	2
Clearance type	Special
Decision	Substantially Equivalent
Received	2026-08-27
Decision date	2026-09-25
Review time (days)	29
Third-party review	No
Applicant location	Incheon, KR
amount percentile	7th 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: 2026-09-25
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: EsTemp Implant (K262983): 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
EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.'s amount: 7th 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 29-day review: this device is a strong predicate for similar products.
Special 510(k): a modification of an existing device.
Posted 40 days ago.

What is the FDAPulse record for EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.?

EsTemp Implant (K262983) by Spident Co., Ltd. was cleared on 2026-09-25 after 29 days of review.

How does EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd. compare to other FDAPulse records?

Its amount of 29 is below the median (7th percentile); smaller records often move faster and face less competition. It is 40 days old, still within a typical 45-day follow-up window.

EsTemp Implant (K262983) vs. top 3 peers

Organization	Location	Record date
EsTemp Implant (K262983)	KR	2026-09-25
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 EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd. and peer dental records

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