Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004140838

FEI Number

3004140838

Entity Name

SDI LTD.

City/State/Country

BAYSWATER Victoria, AU

Establishment Address

3-15 BRUNSDON ST., BAYSWATER Victoria 3153, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SDI LTD. (Owner Number: 9002445)

Owner / Operator Contact Address

3 - 15 BRUNSDON ST., --, BAYSWATER, VICTORIA, AU-NOTA 3153, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081273

PMA Number

N/A

All Registered Proprietary Names

Pola Fresh Freedom Set PP Riva Star Adhesive 1 Go FROG Riva Bond LC Polishing Paste Stela Capsule System Conseal F Conseal Grey Conseal White Riva Coat Riva Conditioner Riva Protect PLS-96P PL Spherical PD Spherical Benco Admix Stae Riva Light Cure Riva LC HV Riva Light Cure HV Ultramat 2 Ultramat S Capsule Mixer Riva Silver Galloy GS 80 GS 80 Spherical Set riva F400 Ultracaps Lojic + Riva Luting Plus Riva Luting Aura eASY Aura Bulk Fill Aura Riva Applicator Riva Applicator 2 Points Complet Applicator Riva Applicator 2 Black Alloybond Adhesive 1 Bonding Resin Etchant liquid Lok Wave Wave MV Wave HV Ultracaps S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2026-01-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-06
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2019-05-05
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2019-05-05
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-28
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-01-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-28
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2014-08-25
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-01-16
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-01-16
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-11-15
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-11-15
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2008-01-28
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2011-10-24
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-28
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2008-01-28
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	1994-05-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-28
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2010-01-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-11-15
DZS	Capsule, Dental, Amalgam	Dental	Class 1	872.3110	1994-05-02
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-28
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-01-04
KXR	Applicator, Resin	Dental	Class 1	872.3140	2014-08-27
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-11-15
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-15
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2008-05-25
ELY	Mercury	Dental	Class 2	872.3070	2008-05-25
OIV	Dental Amalgam	Dental	Class 2	872.3070	2008-05-25

Official Correspondent

Valeriia Tkachenko

US Agent Details

Michele Teehan Email: michele.teehan@sdi.com.au Phone: (630) 3619200

Related Public Records

Same Entity

SDI LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004140838. Last updated year: 2026. Please use registration number 3004140838 when referencing this establishment in official correspondence.