Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007113445

FEI Number

3007113445

Entity Name

medmix Deutschland GmbH

City/State/Country

Kiel Schleswig-Holstein, DE

Establishment Address

Zum Kesselort 53, Kiel Schleswig-Holstein 24149, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

medmix Deutschland GmbH (Owner Number: 10053472)

Owner / Operator Contact Address

Zum Kesselort 53, Kiel, DE-SH 24149, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endo Evacuation Needles Suction Needles Flexible Steel Endo Irrigation Needles Endo Irrigation Needles Painless Steel Prelude One UD GLUMA DESENSITIZER/GLUMA 3 PRIMER IBOND TOTAL ETCH iBond Universal & iBond Ceramic Primer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-08-11
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2016-12-08
DZM	Needle, Dental	Dental	Class 1	872.4730	2016-12-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-08-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-12-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-08-16
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-12-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-08-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-08-16
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2026-01-06
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-04-19
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-11-27
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2017-08-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-11-27
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2025-11-27
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-02-20
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-11-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-11-27
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-12-08

Official Correspondent

Ulf Lempfert

US Agent Details

Joe Bradley Email: Joe.Bradley@medmix.com Phone: (603) 6812713

Related Public Records

Same Entity

medmix Deutschland 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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22

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.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007113445. Last updated year: 2026. Please use registration number 3007113445 when referencing this establishment in official correspondence.