Not currently registered with FDA under this name
Handpiece Unlimited
Luebeck, Germany. Named as applicant on 1 dental 510(k) clearance between 2002 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12002–2002
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Handpiece Unlimited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Oct 2002 | K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: MK-dent GmbH (1).
Sources
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 of the most recent filing, which can be a US agent.