# Osstem Germany GmbH

- Location (FDA's records): Fariless Hills, PA
- FDA decisions: 1 (2014–2014): 1 510(k) clearance
- Product codes: ELW (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (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
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Kettenbach GmbH & Co. KG: 1 (https://510kreport.com/company/kettenbach)
- Roydent Dental Products, Inc.: 1 (https://510kreport.com/company/roydent-dental-products)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)

## Firms that cite its devices most
- Osstem Implant Co., Ltd.: 2 (https://510kreport.com/company/osstem-implant)

## Its most-cited devices
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light (2014), cited by 2

## Recent decisions
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light (Mar 7, 2014)

Source page: https://510kreport.com/company/osstem-germany