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
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)