# Dentsleeve Pty., Ltd.

- Location (FDA's records): Parkside South Australia, AU
- FDA decisions: 3 (1998–2001): 3 510(k) clearances
- Product codes: FFX (2), KLA (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K980946: Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump (1998), cited by 1

## Recent decisions
- K013154: Mark II/Mark Iii Manometric Perfusion Pump (Oct 19, 2001)
- K983665: Manometric Assemblies (May 17, 1999)
- K980946: Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump (Jun 8, 1998)

Source page: https://510kreport.com/company/dentsleeve