FDA Registration Active 🇩🇪 Germany

MK-dent GmbH

Reg #: 3003114027 · FEI: 3003114027 · Expires 2026
Products
2
Proprietary Names
130
Establishment Types
2
Classifications
2

Registration Details

Registration Name
MK-dent GmbH
Registration Number
3003114027
FEI Number
3003114027
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Marie-Curie-Str. 2
City
Bargteheide Schleswig-Holstein
Country
DE

Regulatory Submissions

510(k) Number
K032234

Owner / Operator

Firm Name
MK-dent GmbH
Operator Number
10037735
Address
Marie-Curie-Str. 2
City
Bargteheide
State
Schleswig-Holstein
Postal Code
22941
Country
DE
Correspondent
Florian Kleene

Products

Device Name Product Code
Handpiece, Air-Powered, Dental EFB
Material, Tooth Shade, Resin EBF

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 LBH11C BASIC LINE Contra Angle Latch Type Head LE16 ECO LINE Contra Angle Handpiece LC01 CLASSIC LINE Straight Handpiece LE54LP ECO LINE Contra Angle Handpiece with Light LP15L PRIME LINE Contra Angle Body with Light LP74L PRIME LINE Contra Angle Body with Light LCH16 CLASSIC LINE Contra Angle Head LE54L ECO LINE Contra Angle Handpiece with Light LC11L CLASSIC LINE Contra Angle Body with Light LE27 ECO LINE Contra Angle Handpiece LCH21 CLASSIC LINE Contra Angle Head LP01L PRIME LINE Straight Handpiece with Light LE11 ECO LINE Contra Angle Handpiece LP27L PRIME LINE Contra Angle Body with Light LPH21 PRIME LINE Contra Angle Head LE54 ECO LINE Contra Angle Handpiece LCH21P CLASSIC LINE Contra Angle Prophy Head LB11/11 BASIC LINE Contra Angle Handpiece LB01W BASIC LINE Straight Handpiece LC27L CLASSIC LINE Contra Angle Body with Light LB11W BASIC LINE Contra Angle Handpiece LC11 CLASSIC LINE Contra Angle Body LE01 ECO LINE Straight Handpiece LP11L PRIME LINE Contra Angle Body with Light LE16L ECO LINE Contra Angle Handpiece with Light LB11/11C BASIC LINE Contra Angle Handpiece LBH11 BASIC LINE Contra Angle Head LE148L ECO LINE Contra Angle Handpiece with Light LE21 ECO LINE Contra Angle Handpiece LCH11 CLASSIC LINE Contra Angle Head LE21L ECO LINE Contra Angle Handpiece with Light LB41/11P BASIC LINE Contra Angle Handpiece LE148 ECO LINE Contra Angle Handpiece LB41/11 BASIC LINE Contra Angle Handpiece LE11L ECO LINE Contra Angle Handpiece with Light LE01L ECO LINE Straight Handpiece with Light LE15 ECO LINE Contra Angle Handpiece LC01L CLASSIC LINE Straight Handpiece with Light LE54P ECO LINE Contra Angle Handpiece LPH16 PRIME LINE Contra Angle Head LB02 BASIC LINE Straight Handpiece LC74 CLASSIC LINE Contra Angle Body LE148LP ECO LINE Contra Angle Handpiece with Light LB01 BASIC LINE Straight Handpiece LC27 CLASSIC LINE Contra Angle Body LE148P ECO LINE Contra Angle Handpiece LPH11 PRIME LINE Contra Angle Head LE15L ECO LINE Contra Angle Handpiece with Light LBH11P BASIC LINE Contra Angle Prophy Head LE21P ECO LINE Contra Angle Handpiece LE27L ECO LINE Contra Angle Handpiece with Light LC74L CLASSIC LINE Contra Angle Body with Light AM1002 Airmotor, 2 holes, 2000 rpm AM0002 Airmotor, 2 holes, 2000 rpm LE74 ECO LINE Contra Angle Handpiece LP54L PRIME LINE Contra Angle Handpiece with Light AM1006 Airmotor with LED, 4 holes, 2 pin, 2000 rpm AM0004 Airmotor, 4 holes, 2000 rpm AM1004 Airmotor, 4 holes, 2000 rpm AM0012 Airmotor, 2 holes, 2000 rpm LE74L ECO LINE Contra Angle Handpiece with Light AM0014 Airmotor, 4 holes, 2000 rpm AM1116 Airmotor with LED, 4 holes, 2 pin, 2000 rpm

Establishment Types

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