# Coltene/Whaledent GmbH & Co. Kg (foreign exporter, LANGENAU Baden-Wurttemberg, DE): 2 new FDA device listings, incl. handpiece, direct drive, ac-powered

**Score:** 40/100

| 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 | Handpiece, Direct Drive, Ac-Powered; Resin, Root Canal Filling |
| Product codes | EKX, KIF |
| Device classes | Class I, Class II |
| Medical specialties | Dental |
| Brand names | CanalPro X-Move; CanalPro CalciSeal |
| First new listing | 2026-08-12 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 8010629 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
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.