Where does the data come from?

openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Coltene/Whaledent GmbH & Co. Kg (foreign exporter, LANGENAU Baden-Wurttemberg, DE): 2 new FDA device listings, incl. resin, root canal filling

Q: How to monitor Coltene/Whaledent GmbH & Co. Kg and peer foreign exporter records

DeviceEstablishmentPulse lists new DeviceEstablishmentPulse records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) as they are published; a free weekly email digest and paid alerts follow Delaware records like this one.

Coltene/Whaledent GmbH & Co. Kg (LANGENAU Baden-Wurttemberg, Delaware): 2 new FDA device listings, incl. resin, root canal filling. Its amount of 2 is above the median of 1 (69th percentile). Dated 85 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of 2026-10-28 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 36 related DE DeviceEstablishmentPulse records and the 5-column CSV export.

Field	Value
Establishment	Coltene/Whaledent GmbH & Co. Kg
Owner / operator	COLTENE Holding AG
Role	Foreign exporter
Establishment types	Export Device to the United States But Perform No Other Operation on Device
Location	LANGENAU Baden-Wurttemberg, DE
New listings	2
Devices	Resin, Root Canal Filling; Handpiece, Direct Drive, Ac-Powered
Product codes	KIF, EKX
Device classes	Class I, Class II
Medical specialties	Dental
Brand names	CanalPro CalciSeal; CanalPro X-Move
First new listing	2026-08-12
Latest new listing	2026-08-12
FDA registration number	8010629
Registration expires	2026-12-31
amount percentile	69th of 2,570 (median 1, 2.0x median)
Peer records CSV (37 DE records)	🔒 Click to unlock →
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Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
Record date: 2026-08-12
Data refreshed: 2026-10-28
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Coltene/Whaledent GmbH & Co. Kg and 37 Delaware peers

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

Delaware DeviceEstablishmentPulse records like this one: 37
Coltene/Whaledent GmbH & Co. Kg's amount: 69th percentile of 2,570 records
Timing: Low: older than 30 days
Estimated pipeline if you contact every Delaware peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

40 / 100 Score

Class II or III devices: QMS and regulatory demands.

What is the DeviceEstablishmentPulse record for Coltene/Whaledent GmbH & Co. Kg in LANGENAU Baden-Wurttemberg, Delaware?

Coltene/Whaledent GmbH & Co. Kg (LANGENAU Baden-Wurttemberg, DE), a foreign exporter, added 2 FDA device listings on 2026-08-12.

How does Coltene/Whaledent GmbH & Co. Kg compare to other Delaware DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 85 days old; check the official source for later updates before acting.

Coltene/Whaledent GmbH & Co. Kg vs. top 3 peers

Organization	Location	Amount	Percentile	Record date
Coltene/Whaledent GmbH & Co. Kg	LANGENAU Baden-Wurttemberg, DE	2	69th	2026-08-12
Optikal (Southgate) Ltd	Borehamwood, GB	3	77th	2026-10-13
Loudwater Trade Finance Ltd	LONDON England, GB	3	77th	2026-10-09
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi	Cankaya Ankara, TR	9	92nd	2026-10-17

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.