Data / Medical devices / Germany / Cristaline Aligners GMBH

Cristaline Aligners GMBH: FDA-registered device maker in Pforzheim Baden-Wurttemberg, Germany, 1 510(k) clearance

Cristaline Aligners GMBH is registered with the FDA (registration 3035691085) in Pforzheim Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3035691085

Address

Hanauer Strasse 1-5, Pforzheim Baden-Wurttemberg, Germany, 75181

Owner or operator

Cristaline Aligners GmbH (10092474)

Roles

Manufacturer

First device listed

January 12, 2025

Registered through

2026

Brand names listed

Cristaline Aligners, Sigma Aligners

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.