Manufacturer registered with FDA

Cristaline Aligners GmbH

Pforzheim, Germany. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10092474Manufacturer1 clearance in five years

Device types listed: 1
Brands and models: 2
510(k) clearances: 12024–2024
Markets registered in: 1United States
Establishments: 1Germany

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Cristaline Aligners GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Cristaline AlignersSigma Aligners	2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Cristaline Aligners GmbH as the applicant.

Decided	510(k)	Device	Device type
19 Dec 2024	K242892	Cristaline Aligners Z FLX	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
CRISTALINE ALIGNERS GMBHFDA reg. 3035691085	Pforzheim Baden-Wurttemberg, Germany	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10092474). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.