# W&H Dentalwerk Buermoos GmbH

- Location (FDA's records): Buermoos, AT
- FDA decisions: 18 (1999–2026): 18 510(k) clearances
- Product codes: EBW (5), EFB (3), EKX (3), DZI (2), ERL (1), KMW (1), DZA (1), EGM (1), EGS (1)
- Predicates its devices cite: 21 (8 its own); citations of its devices by later devices: 35 (8 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- A-Dec, Inc.: 3 (https://510kreport.com/company/a-dec)
- Mectron S.P.A.: 2 (https://510kreport.com/company/mectron)
- W&H Dentalwerk Bürmoos GmbH: 2 (https://510kreport.com/company/w-h-dentalwerk-burmoos)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Young Dental Manufacturing Co. 1, LLC: 1 (https://510kreport.com/company/young-dental-manufacturing-co-1)
- Intra Vantage, Inc.: 1 (https://510kreport.com/company/intra-vantage)
- Nakanishi, Inc.: 1 (https://510kreport.com/company/nakanishi)

## Firms that cite its devices most
- Nakanishi, Inc.: 4 (https://510kreport.com/company/nakanishi)
- Saeshin Precision Co., Ltd.: 4 (https://510kreport.com/company/saeshin-precision)
- Anthogyr: 4 (https://510kreport.com/company/anthogyr)
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Bien-Air Dental, SA: 2 (https://510kreport.com/company/bien-air-dental)
- W&H Dentalwerk Bürmoos GmbH: 2 (https://510kreport.com/company/w-h-dentalwerk-burmoos)
- Nouvag AG: 2 (https://510kreport.com/company/nouvag)
- Dentalhitec: 1 (https://510kreport.com/company/dentalhitec)

## Its most-cited devices
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11 (2001), cited by 10
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories (2006), cited by 8
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor (2009), cited by 4
- K181858: Electric Handpiece Motor (2019), cited by 3
- K143704: Advanced Air System (2015), cited by 2
- K080939: Surgical Handpieces, Mikro Saw Handpieces (2008), cited by 2

## Recent decisions
- K253776: Implantmed Plus II & Piezomed Plus II Module (Jun 18, 2026)
- K243280: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (Jul 3, 2025)
- K201703: PROXEO Twist Cordless Polishing System PL-40 H (Feb 24, 2021)
- K181858: Electric Handpiece Motor (Mar 26, 2019)
- K171553: W&H Assistina Twin (Dec 8, 2017)
- K143704: Advanced Air System (Nov 23, 2015)
- K133488: Piezomed (Oct 16, 2014)
- K100600: Prosthodontic Screwdriver , Model IA-400 (Jul 9, 2010)

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