Data / Medical devices / Germany / MK-dent GmbH
MK-dent GmbH: FDA-registered device maker in Bargteheide Schleswig-Holstein, Germany, 3 510(k) clearances
MK-dent GmbH is registered with the FDA (registration 3003114027) in Bargteheide Schleswig-Holstein, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 3, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003114027
- Address
- Marie-Curie-Str. 2, Bargteheide Schleswig-Holstein, Germany, 22941
- Owner or operator
- MK-dent GmbH (10037735)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 11, 2011
- Registered through
- 2026
- Brand names listed
- AM0002 Airmotor, 2 holes, 2000 rpm, AM0004 Airmotor, 4 holes, 2000 rpm, AM0012 Airmotor, 2 holes, 2000 rpm, AM0014 Airmotor, 4 holes, 2000 rpm, AM1002 Airmotor, 2 holes, 2000 rpm, AM1004 Airmotor, 4 holes, 2000 rpm, AM1006 Airmotor with LED, 4 holes, 2 pin, 2000 rpm, AM1116 Airmotor with LED, 4 holes, 2 pin, 2000 rpm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | EFB | Substantially Equivalent | Mk-Dent GmbH | accessdata.fda.gov |
| October 2, 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | EFB | Substantially Equivalent | Mk-Dent GmbH | accessdata.fda.gov |
| October 24, 2002 | K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | EBF | Substantially Equivalent | Handpiece Unlimited | accessdata.fda.gov |
Compare with other makers
Updated October 3, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.