Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680954

FEI Number

1000293792

Entity Name

DETAX GMBH

City/State/Country

ETTLINGEN Baden-Wurttemberg, DE

Establishment Address

CARL-ZEISS-STR. 4, ETTLINGEN Baden-Wurttemberg D-76275, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DETAX GMBH (Owner Number: 9012556)

Owner / Operator Contact Address

CARL-ZEISS-STR. 4, --, ETTLINGEN, DE-BW 76275, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

bioflex 40 rose 4x50ml protect mold neon-orange 2x100ml direct mold rose-transparent 8x50ml protect mold neon-pink 2x100ml bioflex 40 red 4x50ml aquaplus colormix orange 8x50ml bioflex 40 blue 4x50ml aquaplus colormix yellow 8x50 ml aquaplus colormix red 8x50 ml aquaplus colormix green 8x50ml bioflex 40 transparent 4x50 ml aquaplus colormix blue 8x50 ml protect mold neon-green 2x100ml aquaplus colormix red/blue 8x50ml aquaplus colormix standard pack 8x50ml protect mold neon-yellow 2x100ml VITA VIONIC® DENT RESIN B3 1000g VITA VIONIC® DENT RESIN A1 500g VITA VIONIC® DENT RESIN B3 500g VITA VIONIC® DENT RESIN C2 500g VITA VIONIC® DENT RESIN A2 500g VITA VIONIC® DENT RESIN A1 1000g VITA VIONIC® DENT RESIN C2 1000g VITA VIONIC® DENT RESIN 0M3 500g VITA VIONIC® DENT RESIN 0M3 1000g VITA VIONIC® DENT RESIN A2 1000g VITA VIONIC® DENT RESIN A3 1000g VITA VIONIC® DENT RESIN A3 500g VITA VIONIC® DENT RESIN B1 1000g VITA VIONIC® DENT RESIN A3,5 500g FREEPRINT® crown A3,5 1000g VITA VIONIC® DENT RESIN A3,5 1000g VITA VIONIC® DENT RESIN D3 1000g FREEPRINT® crown A3,5 500g VITA VIONIC® DENT RESIN D3 500g VITA VIONIC® DeNT RESIN B1 500g VITA VIONIC® DENT RESIN 0M3 500g FREEPRINT crown A3,5 1000g VITA VIONIC® DENT RESIN A3,5 500g VITA VIONIC® DENT RESIN D3 500g VITA VIONIC® DENT RESIN A3 500g VITA VIONIC® DENT RESIN A1 1000g VITA VIONIC® DENT RESIN 0M3 1000g VITA VIONIC® DENT RESIN A2 500g FREEPRINT crown A3,5 500g VITA VIONIC® DENT RESIN C2 1000g VITA VIONIC® DENT RESIN C2 500g VITA VIONIC® DENT RESIN A3 1000g VITA VIONIC® DENT RESIN A3,5 1000g VITA VIONIC® DENT RESIN B1 500g VITA VIONIC® DENT RESIN A1 500g VITA VIONIC® DENT RESIN A2 1000g VITA VIONIC® DENT RESIN B3 500g VITA VIONIC® DENT RESIN D3 1000g VITA VIONIC® DENT RESIN B1 1000g VITA VIONIC® DENT RESIN B3 1000g earflex rose 60 shore 8 x 50 ml detax softwear 2 pink-fluorescent 60 shore 2x50ml detax softwear 2 yellow fluorescent 40 shore 2x50ml addition Junior/DIC 4 x 50 ml medicalprint nobreak red-transparent 1000g medicalprint nobreak green-opaque 1000g medicalprint nobreak orange transparent 1000g addition ultra Automix 2 addition supra Automix 2 8x50ml detax softwear 2 rose 40 8x50 ml luxaprint shell white bioplast 25 shore 8 x 50ml medicalprint shell beige 2 1000g medicalprint nobreak purple 1000g Medicalprint nobreak blue-transparent 1000g Medicalprint nobreak white 1000g medicalprint coat medicalprint nobreak dark grey 1000g medicalprint nobreak brown 1000g medicalprint nobreak neon yellow 1000g VITA VIONIC® TRY-IN RESIN A2 500g VITA VIONIC® TRY-IN RESIN 1000g tempofit premium B1 tempofit premium BL freeprint denture flex pink 1000g RS VIVO Denture Flex pink transparent 1000g freeprint denture flex pink transparent 1000g VITA VIONIC® BASE RESIN FLEX pink transparent 1000g VITA VIONIC® BASE RESIN FLEX clear 1000g RS VIVO Denture Flex transparent 1000g Primeprint Splint ST 1000g FREEPRINT splintmaster taff 1000g RS VIVO Splint Flex 1000g Primeprint Splint SF 1000g FREEPRINT splintmaster flex 1000g RS VIVO Splint Hard 1000g

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2010-07-27
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2024-05-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-09-27
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-09-27
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2022-11-22
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2008-01-29
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2016-11-17
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2017-05-23
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-11-27
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2012-05-31
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2006-08-30
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-11-17
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2023-10-18
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2023-10-18
ELW	Material, Impression	Dental	Class 2	872.3660	2013-08-30
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2019-03-21

Official Correspondent

No official correspondent registered.

US Agent Details

Chris Brown Business: Aclivi, LLC Email: acliviconsulting@gmail.com Phone: (810) 3609773

Related Public Records

Same Entity

DETAX 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06

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
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3003169405	MONITEX INDUSTRIAL CO., LTD.	SAN-CHUNG CITY Taipei, TW
3012041047	JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD	Jiujiang City Jiangxi, CN
9680845	SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, MX
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680954. Last updated year: 2026. Please use registration number 9680954 when referencing this establishment in official correspondence.