ClearanceBrief
Company ยท AU

Sdi Limited

FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2022. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
EBFMaterial, Tooth Shade, Resin3
EMACement, Dental2
EFDAmalgamator, Dental, Ac-Powered1
KKXDrape, Surgical, Antimicrobial1
KLEAgent, Tooth Bonding, Resin1
OIVDental Amalgam1
PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 28, 2022K222583Stela Capsule System
Sdi Limited, AU
EBF
Oct 28, 2022K222581Stela Automix System
Sdi Limited, AU
EBF
Aug 30, 2022K214118Riva Cem Automix
Sdi Limited, AU
EMA
Dec 2, 2019K191656Zipbond
Sdi Limited, AU
KLE
Apr 11, 2018K172047Riva Star
Sdi Limited, AU
PHR
Dec 8, 2010K102984AURA
Sdi Limited, AU
EBF
Jul 10, 2008K081273ULTRACAPS S
Sdi , Ltd., AU
OIV
Dec 14, 2007K073043SET PP
Sdi , Ltd., AU
EMA
Apr 4, 1984K833176SDI SURGICAL DRAPE
Sdi
KKX

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 14, 2026SDI Limited
Dentsply Sirona Capsule Mixer Model No. 5546068
Open, Classified		 EFDNone listed
Get alerts for these product codes