Manufacturer registered with FDA
MK-dent GmbH
Bargteheide, Germany. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 130
- 510(k) clearances
- 22003–2005
- Markets registered in
- 11125 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name MK-dent GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | MK-dent GmbH | 2 clearances | 2003–2005 | Below |
| Canada | Health Canada | Registration holder | MK-DENT GMBH | 29 | 2001–2013 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MK-dent Gmbh | 21 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MK-dent GmbH | 18 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MK-DENT GMBHMK-dent GmbH | 14 | 2005–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | MK-Dent GmbH | 13 | 2007–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | MK-dent GmbHmk-dent GmbH | 10 | 2002–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MK-dent GmbH | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MK-dent GmbHMK-dent | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MK-DENT GMBH | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | MK-dent GmbH | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What MK-dent GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AM0002 Airmotor, 2 holes, 2000 rpmAM0004 Airmotor, 4 holes, 2000 rpmAM0012 Airmotor, 2 holes, 2000 rpmAM0014 Airmotor, 4 holes, 2000 rpmAM1002 Airmotor, 2 holes, 2000 rpmAM1004 Airmotor, 4 holes, 2000 rpmAM1006 Airmotor with LED, 4 holes, 2 pin, 2000 rpmAM1116 Airmotor with LED, 4 holes, 2 pin, 2000 rpmHB12 BASIC LINE High Speed HandpieceHB14 BASIC LINE High Speed Handpiece 119 moreHB15L BASIC LINE High Speed Handpiece with LightHB16L BASIC LINE High Speed Handpiece with LightHB21K BASIC LINE High Speed HandpieceHB21KL BASIC LINE High Speed Handpiece with LightHB23K BASIC LINE High Speed HandpieceHB23KL BASIC LINE High Speed Handpiece with LightHC20K CLASSIC LINE High Speed HandpieceHC20KL CLASSIC LINE High Speed Handpiece with LightHC21K CLASSIC LINE High Speed HandpieceHC21KL CLASSIC LINE High Speed Handpiece with LightHC22K CLASSIC LINE High Speed HandpieceHC22KL CLASSIC LINE High Speed Handpiece with LightHC8021K PRIME LINE High Speed HandpieceHE11 ECO LINE High Speed HandpieceHE12 ECO LINE High Speed HandpieceHE14 ECO LINE High Speed HandpieceHE15L ECO LINE High Speed Handpiece with LightHE16L ECO LINE High Speed Handpiece with LightHE17 ECO LINE High Speed HandpieceHE17B ECO LINE High Speed HandpieceHE18 ECO LINE High Speed HandpieceHE20K ECO LINE High Speed HandpieceHE20KL ECO LINE High Speed Handpiece with LightHE21K ECO LINE High Speed HandpieceHE21KL ECO LINE High Speed Handpiece with LightHE21N ECO LINE High Speed HandpieceHE21NL ECO LINE High Speed Handpiece with LightHE21SL ECO LINE High Speed Handpiece with LightHE21W ECO LINE High Speed HandpieceHE21WL ECO LINE High Speed Handpiece with LightHE22K ECO LINE High Speed HandpieceHE22KL ECO LINE High Speed Handpiece with LightHE22N ECO LINE High Speed HandpieceHE22NL ECO LINE High Speed Handpiece with LightHE22W ECO LINE High Speed HandpieceHE22WL ECO LINE High Speed Handpiece with LightHP21KL PRIME LINE High Speed Handpiece with LightHP21NL PRIME LINE High Speed Handpiece with LightHP21SL PRIME LINE High Speed Handpiece with LightHP21WL PRIME LINE High Speed Handpiece with LightHP22KL PRIME LINE High Speed Handpiece with LightHP22NL PRIME LINE High Speed Handpiece with LightHP22WL PRIME LINE High Speed Handpiece with LightLB01 BASIC LINE Straight HandpieceLB01W BASIC LINE Straight HandpieceLB02 BASIC LINE Straight HandpieceLB11/11 BASIC LINE Contra Angle HandpieceLB11/11C BASIC LINE Contra Angle HandpieceLB11W BASIC LINE Contra Angle HandpieceLB41/11 BASIC LINE Contra Angle HandpieceLB41/11P BASIC LINE Contra Angle HandpieceLBH11 BASIC LINE Contra Angle HeadLBH11C BASIC LINE Contra Angle Latch Type HeadLBH11P BASIC LINE Contra Angle Prophy HeadLC01 CLASSIC LINE Straight HandpieceLC01L CLASSIC LINE Straight Handpiece with LightLC11 CLASSIC LINE Contra Angle BodyLC11L CLASSIC LINE Contra Angle Body with LightLC27 CLASSIC LINE Contra Angle BodyLC27L CLASSIC LINE Contra Angle Body with LightLC74 CLASSIC LINE Contra Angle BodyLC74L CLASSIC LINE Contra Angle Body with LightLCH11 CLASSIC LINE Contra Angle HeadLCH16 CLASSIC LINE Contra Angle HeadLCH21 CLASSIC LINE Contra Angle HeadLCH21P CLASSIC LINE Contra Angle Prophy HeadLE01 ECO LINE Straight HandpieceLE01L ECO LINE Straight Handpiece with LightLE11 ECO LINE Contra Angle HandpieceLE11L ECO LINE Contra Angle Handpiece with LightLE148 ECO LINE Contra Angle HandpieceLE148L ECO LINE Contra Angle Handpiece with LightLE148LP ECO LINE Contra Angle Handpiece with LightLE148P ECO LINE Contra Angle HandpieceLE15 ECO LINE Contra Angle HandpieceLE15L ECO LINE Contra Angle Handpiece with LightLE16 ECO LINE Contra Angle HandpieceLE16L ECO LINE Contra Angle Handpiece with LightLE21 ECO LINE Contra Angle HandpieceLE21L ECO LINE Contra Angle Handpiece with LightLE21P ECO LINE Contra Angle HandpieceLE27 ECO LINE Contra Angle HandpieceLE27L ECO LINE Contra Angle Handpiece with LightLE54 ECO LINE Contra Angle HandpieceLE54L ECO LINE Contra Angle Handpiece with LightLE54LP ECO LINE Contra Angle Handpiece with LightLE54P ECO LINE Contra Angle HandpieceLE74 ECO LINE Contra Angle HandpieceLE74L ECO LINE Contra Angle Handpiece with LightLP01L PRIME LINE Straight Handpiece with LightLP11L PRIME LINE Contra Angle Body with LightLP15L PRIME LINE Contra Angle Body with LightLP27L PRIME LINE Contra Angle Body with LightLP54L PRIME LINE Contra Angle Handpiece with LightLP74L PRIME LINE Contra Angle Body with LightLPH11 PRIME LINE Contra Angle HeadLPH16 PRIME LINE Contra Angle HeadLPH21 PRIME LINE Contra Angle HeadLU1011 Premium Service OilLU1022 Premium Service OilLU1031 Premium Service OilQC4012K Quick Connector, 2 holesQC4014K Quick Connector, 4 holesQC4014NT Quick Connector, 4 holesQC4014W Quick Connector, 4 holesQC5015K Quick Connector, 4 holesQC5016K Quick Connector, 4 holes (6 pins)QC5016KW Quick Connector, 4 holes (6 pins)QC5016NT Quick Connector, 4 holes (6 pins)QC5016SW Quick Connector, 4 holes (6 pins)QC5016W Quick Connector, 4 holes (6 pins)QC5116K Quick Connector, 4 holes (6 pins)QC5116KW Quick Connector, 4 holes (6 pins)QC6016K Quick Connector, 4 holes (6 pins)QC6016KW Quick Connector, 4 holes (6 pins)QC6016NT Quick Connector, 4 holes (6 pins)QC6016SW Quick Connector, 4 holes (6 pins)QC6116K Quick Connector, 4 holes (6 pins)QC6116KW Quick Connector, 4 holes (6 pins) | 2011 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | place holder | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names MK-dent GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Oct 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | EFB Dental Air-Powered Handpiece |
| 2 Oct 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Aseptico, Inc. (1).
Also lists devices cleared under other names
MK-dent GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Handpiece Unlimited (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Oct 2002 | K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | Handpiece Unlimited | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MK-dent GmbHFDA reg. 3003114027 | Bargteheide Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037735). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.