# Sdi Limited

- Location (FDA's records): Bayswater, AU
- FDA decisions: 9 (1984–2022): 9 510(k) clearances
- Names in FDA's records: Sdi Limited (6); Sdi , Ltd. (2); Sdi (1)
- Product codes: EBF (3), EMA (2), OIV (1), KLE (1), PHR (1), KKX (1)
- 510(k) review time since 2016: median 114 days, against 103 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 12 (0 its own); citations of its devices by later devices: 1 (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
- Coltene/Whaledent, Inc.: 4 (https://510kreport.com/company/coltene-whaledent)
- 3M Espe AG: 3 (https://510kreport.com/company/3m-espe)
- 3M Company: 2 (https://510kreport.com/company/3m)
- 3M Espe Dental Products: 1 (https://510kreport.com/company/3m-espe-dental-products)
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Cooley Consulting, Inc.: 1 (https://510kreport.com/company/cooley-consulting)

## Firms that cite its devices most
- Den-Mat Holdings, LLC: 1 (https://510kreport.com/company/den-mat-holdings)

## Its most-cited devices
- K222581: Stela Automix System (2022), cited by 1

## Recent decisions
- K222581: Stela Automix System (Oct 28, 2022)
- K222583: Stela Capsule System (Oct 28, 2022)
- K214118: Riva Cem Automix (Aug 30, 2022)
- K191656: Zipbond (Dec 2, 2019)
- K172047: Riva Star (Apr 11, 2018)
- K102984: AURA (Dec 8, 2010)
- K081273: Ultracaps S (Jul 10, 2008)
- K073043: SET PP (Dec 14, 2007)

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