# Sirona Dental Systems GmbH

- Location (FDA's records): Bensheim, DE
- FDA decisions: 42 (1998–2016): 42 510(k) clearances
- Product codes: MUH (7), EIH (6), EIA (4), OAS (3), ELC (3), EHD (3), GEX (3), ELW (3), EFB (2), NHA (2), EKX (2), EGS (1)
- Predicates its devices cite: 73 (20 its own); citations of its devices by later devices: 91 (20 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
- Pelton & Crane Co.: 4 (https://510kreport.com/company/pelton-crane)
- Ceram Optec, Inc.: 4 (https://510kreport.com/company/ceram-optec)
- A-Dec, Inc.: 3 (https://510kreport.com/company/a-dec)
- Electro Medical Systems SA: 3 (https://510kreport.com/company/electro-medical-systems)
- J. Morita USA, Inc.: 3 (https://510kreport.com/company/j-morita-usa)
- Nobel Biocare AB: 3 (https://510kreport.com/company/nobel-biocare)
- Institut Straumann AG: 3 (https://510kreport.com/company/institut-straumann)
- Biomet 3i, Inc.: 3 (https://510kreport.com/company/biomet-3i)

## Firms that cite its devices most
- Dentsply Sirona: 11 (https://510kreport.com/company/dentsply-sirona)
- Kaltenbach & Voigt GmbH: 3 (https://510kreport.com/company/kaltenbach-voigt)
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- VATECH Co., Ltd.: 2 (https://510kreport.com/company/vatech)
- BioHorizons Implant Systems, Inc.: 2 (https://510kreport.com/company/biohorizons-implant-systems)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Altatec GmbH: 2 (https://510kreport.com/company/altatec)
- Nakanishi, Inc.: 2 (https://510kreport.com/company/nakanishi)

## Its most-cited devices
- K053161: Sirolaser (2006), cited by 8
- K111421: Sirona Dental Cad/Cam System (2012), cited by 7
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories (2003), cited by 6
- K983242: Sirona C8 Dental Operative Unit with Accessories (1998), cited by 5
- K100152: Sirona Cad/Cam System (2010), cited by 5
- K150217: Orthophos SL (2015), cited by 4

## Recent decisions
- K160099: CEREC SpeedGlaze (Jun 2, 2016)
- K151045: TENEO Dental Treatment Unit and Accessories (Jul 24, 2015)
- K150909: INTEGO Family and Accesories (Jul 17, 2015)
- K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (Jul 2, 2015)
- K150217: Orthophos SL (May 8, 2015)
- K131319: T1/T2/T3 Turbine Family (May 30, 2014)
- K132773: Sidexis 4 (Dec 11, 2013)
- K123664: Incoris ZI (Apr 8, 2013)

Source page: https://510kreport.com/company/sirona-dental-systems