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=K261327

Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S

Q: How to monitor Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S 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.

Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S: 510(k) cleared for Elos Medtech Pinol A/S. Its amount of 161 is above the median of 138 (59th percentile). Dated 35 days ago, it serves as a historical benchmark. 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: 161 · 59th percentile of 414 FDAPulse records · 1.2x the median

Free preview: all 14 published fields of this record are shown below. Locked: 3 related DK FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K261327
Device	Elos Accurate Hybrid Base
Applicant	Elos Medtech Pinol A/S
Specialty / panel	Dental
Product code	NHA
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2026-04-22
Decision date	2026-09-30
Review time (days)	161
Third-party review	No
Applicant location	Goerloese, DK
amount percentile	59th of 414 (median 138, 1.2x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-30
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: Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S and 4 DK peers

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

DK FDAPulse records like this one: 4
Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S's amount: 59th percentile of 414 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every DK peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

48 / 100 Predicate Speed & CAPA Advisory Opportunity Score

161-day review, longer than typical.
Posted 35 days ago.

What is the FDAPulse record for Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S?

Elos Accurate Hybrid Base (K261327) by Elos Medtech Pinol A/S was cleared on 2026-09-30 after 161 days of review.

How does Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S compare to other FDAPulse records?

Its amount of 161 sits in the upper half (59th percentile) of 414 records; the median is 138. It is 35 days old, still within a typical 45-day follow-up window.

Elos Accurate Hybrid Base (K261327) vs. top 3 peers

Organization	Location	Record date
Elos Accurate Hybrid Base (K261327)	DK	2026-09-30
LuxDesign (K260421)	IL	2026-10-23
Mobile Dental Solution (Model	CN	2026-10-23
Forza (K260136)	CA	2026-10-06

How to monitor Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S and peer dental records

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