Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007791519

FEI Number

3007791519

Entity Name

anax dent GmbH

City/State/Country

Stuttgart Baden-Wurttemberg, DE

Establishment Address

Dreifelderstrasse 5, Stuttgart Baden-Wurttemberg 70599, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

anax dent GmbH (Owner Number: 10028652)

Owner / Operator Contact Address

Dreifelderstr. 5, Stuttgart, DE-BW 70599, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102341

PMA Number

N/A

All Registered Proprietary Names

Visco III anaxBLEND anaxGUM anaxPINK New Outline anaxGLAZE PMMA BLANKS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2013-05-30
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-02-02
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2009-02-20
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2013-05-30

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

anax dent GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3001389926	DENTAL MANUFACTURING SPA	Badia Polesine Rovigo, IT
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007791519. Last updated year: 2026. Please use registration number 3007791519 when referencing this establishment in official correspondence.