# W&H Dentalwerk Bürmoos GmbH

- Location (FDA's records): Buermoos, AT
- FDA decisions: 5 (2004–2026): 5 510(k) clearances
- Names in FDA's records: W&H Dentalwerk Bürmoos GmbH (2); W&H Dentalwerk Burmoos GmbH (2); W&H Dentalwerk Burmoos (1)
- Product codes: EFB (2), EBW (2), DZI (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- A-Dec, Inc.: 2 (https://510kreport.com/company/a-dec)
- W&H Dentalwerk Buermoos GmbH: 2 (https://510kreport.com/company/w-h-dentalwerk-buermoos)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Nakanishi, Inc.: 3 (https://510kreport.com/company/nakanishi)
- W&H Dentalwerk Buermoos GmbH: 2 (https://510kreport.com/company/w-h-dentalwerk-buermoos)
- Guilin Woodpecker Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- Innovative Medical Manufacturing Co.: 1 (https://510kreport.com/company/innovative-medical-manufacturing)

## Its most-cited devices
- K161957: W&H Implantmed SI-1015 incl. Accessories (2016), cited by 4
- K162926: Air-Powered Handpieces and Handpiece Attachments (2017), cited by 2
- K041124: Irrigation Tubing Set 2.2M and 3.8M (2004), cited by 1

## Recent decisions
- K253655: Angled Screwdriver MED (M-SD090) (Jul 31, 2026)
- K242179: Synea Fusion Handpieces (Intensiv & Profin) (Feb 28, 2025)
- K162926: Air-Powered Handpieces and Handpiece Attachments (Feb 23, 2017)
- K161957: W&H Implantmed SI-1015 incl. Accessories (Nov 23, 2016)
- K041124: Irrigation Tubing Set 2.2M and 3.8M (Jun 7, 2004)

Source page: https://510kreport.com/company/w-h-dentalwerk-burmoos