Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003114027

FEI Number

3003114027

Entity Name

MK-dent GmbH

City/State/Country

Bargteheide Schleswig-Holstein, DE

Establishment Address

Marie-Curie-Str. 2, Bargteheide Schleswig-Holstein 22941, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

MK-dent GmbH (Owner Number: 10037735)

Owner / Operator Contact Address

Marie-Curie-Str. 2, Bargteheide, DE-SH 22941, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021250

PMA Number

N/A

All Registered Proprietary Names

QC6016SW Quick Connector, 4 holes (6 pins) HC22K CLASSIC LINE High Speed Handpiece HB12 BASIC LINE High Speed Handpiece QC4012K Quick Connector, 2 holes HE22WL ECO LINE High Speed Handpiece with Light HE21K ECO LINE High Speed Handpiece QC6016K Quick Connector, 4 holes (6 pins) HE21WL ECO LINE High Speed Handpiece with Light QC5016NT Quick Connector, 4 holes (6 pins) QC5016K Quick Connector, 4 holes (6 pins) HE11 ECO LINE High Speed Handpiece HP22NL PRIME LINE High Speed Handpiece with Light QC5016SW Quick Connector, 4 holes (6 pins) HE18 ECO LINE High Speed Handpiece QC5116K Quick Connector, 4 holes (6 pins) HE21W ECO LINE High Speed Handpiece HE22KL ECO LINE High Speed Handpiece with Light HE22W ECO LINE High Speed Handpiece HE14 ECO LINE High Speed Handpiece HB21KL BASIC LINE High Speed Handpiece with Light HE17B ECO LINE High Speed Handpiece HB21K BASIC LINE High Speed Handpiece QC6116KW Quick Connector, 4 holes (6 pins) HB15L BASIC LINE High Speed Handpiece with Light QC5116KW Quick Connector, 4 holes (6 pins) HC8021K PRIME LINE High Speed Handpiece QC5015K Quick Connector, 4 holes QC5016W Quick Connector, 4 holes (6 pins) HE21SL ECO LINE High Speed Handpiece with Light HP21NL PRIME LINE High Speed Handpiece with Light QC6016NT Quick Connector, 4 holes (6 pins) HP21KL PRIME LINE High Speed Handpiece with Light HP21SL PRIME LINE High Speed Handpiece with Light QC5016KW Quick Connector, 4 holes (6 pins) HE20KL ECO LINE High Speed Handpiece with Light HP22KL PRIME LINE High Speed Handpiece with Light HP21WL PRIME LINE High Speed Handpiece with Light HE15L ECO LINE High Speed Handpiece with Light HB23K BASIC LINE High Speed Handpiece HE21N ECO LINE High Speed Handpiece HC20KL CLASSIC LINE High Speed Handpiece with Light HC22KL CLASSIC LINE High Speed Handpiece with Light QC4014NT Quick Connector, 4 holes HE20K ECO LINE High Speed Handpiece HE22K ECO LINE High Speed Handpiece HE22NL ECO LINE High Speed Handpiece with Light HB16L BASIC LINE High Speed Handpiece with Light QC6116K Quick Connector, 4 holes (6 pins) HE16L ECO LINE High Speed Handpiece with Light HB23KL BASIC LINE High Speed Handpiece with Light HE21NL ECO LINE High Speed Handpiece with Light HB14 BASIC LINE High Speed Handpiece QC4014K Quick Connector, 4 holes QC4014W Quick Connector, 4 holes HE17 ECO LINE High Speed Handpiece HC20K CLASSIC LINE High Speed Handpiece HE21KL ECO LINE High Speed Handpiece with Light QC6016KW Quick Connector, 4 holes (6 pins) HE22N ECO LINE High Speed Handpiece HC21K CLASSIC LINE High Speed Handpiece HC21KL CLASSIC LINE High Speed Handpiece with Light HE12 ECO LINE High Speed Handpiece HP22WL PRIME LINE High Speed Handpiece with Light LU1011 Premium Service Oil LU1031 Premium Service Oil LU1022 Premium Service Oil place holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2011-08-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-08-11

Official Correspondent

Florian Kleene

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

MK-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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
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
3017619674	FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.	Foshan Guangdong, CN
3014471275	TUNAP GMBH & CO. KG	Wolfratshausen Bavaria, DE
2133714	INTER-MED, INC.	Racine, WI, US
2246821	MTI PRECISION PRODUCTS	Coatesville, PA, US
8010468	GEBR. BRASSELER GMBH & CO. KG	LEMGO North Rhine-Westphalia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003114027. Last updated year: 2026. Please use registration number 3003114027 when referencing this establishment in official correspondence.