Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035691085

FEI Number

3035691085

Entity Name

CRISTALINE ALIGNERS GMBH

City/State/Country

Pforzheim Baden-Wurttemberg, DE

Establishment Address

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

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cristaline Aligners GmbH (Owner Number: 10092474)

Owner / Operator Contact Address

Hanauer Strasse 1-5, Pforzheim, DE-BW 75181, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242892

PMA Number

N/A

All Registered Proprietary Names

Sigma Aligners Cristaline Aligners

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-01-12

Official Correspondent

Patsy Trisler

US Agent Details

Patsy Trisler Business: Trisler Consulting dba Email: trisconsult@icloud.com Phone: (301) 7855597

Related Public Records

Same Entity

Cristaline Aligners GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035691085. Last updated year: 2026. Please use registration number 3035691085 when referencing this establishment in official correspondence.