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=K260913

CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV

Q: How to monitor CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV and peer dental records

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CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV: 510(k) cleared for Materialise NV. Its amount of 204 is above the median of 138 (68th percentile). Dated 26 days ago, it is in the active follow-up window. Score 48/100. 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: 204 · 68th percentile of 414 FDAPulse records · 1.5x the median

Free preview: all 14 published fields of this record are shown below. Locked: 4 related BE FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K260913
Device	CMF Titanium Splints
Applicant	Materialise NV
Specialty / panel	Dental
Product code	DZJ
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-03-19
Decision date	2026-10-09
Review time (days)	204
Third-party review	No
Applicant location	Leuven, BE
amount percentile	68th of 414 (median 138, 1.5x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-09
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: CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV and 5 BE peers

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

BE FDAPulse records like this one: 5
CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV's amount: 68th percentile of 414 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every BE peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

48 / 100 Predicate Speed & CAPA Advisory Opportunity Score

204-day review, longer than typical.
Posted 26 days ago.

What is the FDAPulse record for CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV?

CMF Titanium Splints (K260913) by Materialise NV was cleared on 2026-10-09 after 204 days of review.

How does CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV compare to other FDAPulse records?

Its amount of 204 sits in the upper half (68th percentile) of 414 records; the median is 138. It is 26 days old, still within a typical 45-day follow-up window.

CMF Titanium Splints (K260913) vs. top 3 peers

Organization	Location	Record date
CMF Titanium Splints (K260913)	BE	2026-10-09
LuxDesign (K260421)	IL	2026-10-23
Mobile Dental Solution (Model	CN	2026-10-23
Forza (K260136)	CA	2026-10-06

Compare CMF Titanium Splints (K260913) vs Wishbone HAE (K260096) →

How to monitor CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV and peer dental records

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