W & H Dentalwerk is one of 31 FDA 510(k) medical device manufacturers from Austria in the dataset, ranked by real submission volume.
W & H Dentalwerk - FDA 510(k) Cleared Devices
Recent clearances: ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
1
Total
1
Cleared
0
Denied
W & H Dentalwerk, is an Austrian manufacturer of dental equipment and instruments. The company operates with a manufacturing facility in Burmoos, Austria, and serves dental professionals worldwide through a comprehensive product portfolio spanning restorative care, sterilization, imaging, oral surgery, and laboratory applications.
The company has received 1 FDA 510(k) clearance from 1 total submission. This regulatory milestone dates to 1998, reflecting the company's historical presence in the U.S. dental device market. W & H Dentalwerk is currently inactive with no FDA submissions recorded in the past decade, making this a historical regulatory record.
Historical FDA 510(k) cleared devices include the ELCOMED 100 and ELCOMED 200 series, which represent the company's core competency in motorized handpieces and surgical instrumentation for dental professionals. These products reflect W & H's focus on precision engineering for clinical and laboratory environments.
For detailed information on device names, product codes, and clearance dates, consult the FDA 510(k) database or contact the company directly.
FDA 510(k) Regulatory Record - W & H Dentalwerk
1 devices