Cristaline Aligners GmbH
GermanyFDA 510(k) applicant, unverified FDA FEI 3035691085
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Cristaline Aligners GmbH makes
Cristaline Aligners GmbH manufactures clear aligner systems, including the Cristaline Aligners Z FLX, designed for orthodontic tooth movement and alignment.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices and is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Cristaline Aligners Z FLX Ref K242892
510(k) 510(k)
Company details
- FDA FEI number
- 3035691085
- Address
- Hanauer Strasse 1-5, Pforzheim Baden-Wurttemberg
Frequently asked questions
How many devices does Cristaline Aligners GmbH have in the registry?
The registry currently lists 1 device for Cristaline Aligners GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cristaline Aligners GmbH's devices?
Among its 1 most recently registered device, Cristaline Aligners GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Cristaline Aligners GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cristaline Aligners GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cristaline Aligners GmbH in the registry?
The most recently registered devices listed for Cristaline Aligners GmbH include Cristaline Aligners Z FLX.