Pure Global

Bisco Dental Cement - HSA Registration DE0013081

Access comprehensive regulatory information for Bisco Dental Cement in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013081 and owned by Bisco Inc. The device was registered on June 04, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0013081
Bisco Dental Cement
HSA Registration Number: DE0013081
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Compounds used in dentistry/ orthodontics typically to bond a dental prosthesis to the anatomy (luting agent), to form an insulating layer under dental restorations. It includes accessories e.g. mixing pad, dispensor and other components required to complete the cementing procedure.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0013081
Registration Date
June 04, 2013
Change Notification Approval Date
March 19, 2024
Retention Due Date
June 03, 2025
Product Owner
Short Name
Bisco
Address
1100 W, Irving Park Road, Schaumburg, IL 60193, UNITED STATES
Registrant
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Importer
Address
6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Model Information
Model Name(s)
Duo-Link Universal 1 Dual-Syringe Pkg (Universal) Duo-Link Universal System Kit Duo-Link Universal 1 Dual-Syringe Pkg (Milky White) Porcelain Bonding Resin CHOICE 2 STARTER KIT Choice 2 Starter Kit CHOICE 2 A1 SYRINGE REFILL CHOICE 2 A2 SYRINGE REFILL CHOICE 2 A3 SYRINGE REFILL CHOICE 2 B1 SYRINGE REFILL CHOICE 2 MILKY BRIGHT SYRINGE REFILL CHOICE 2 MILKY OPAQUE SYRINGE REFILL CHOICE 2 UNIVERSAL OPAQUE SYRINGE REFILL CHOICE 2 TRANSPARENT SYRINGE REFILL CHOICE 2 TRY-IN PASTE A1 REFILL CHOICE 2 TRY-IN PASTE A2 REFILL CHOICE 2 TRY-IN PASTE A3 REFILL CHOICE 2 TRY-IN PASTE B1 REFILL CHOICE 2 TRY-IN PASTE MILKY BRIGHT REFILL CHOICE 2 TRY-IN PASTE MILKY OPAQUE REFILL CHOICE 2 TRY-IN PASTE UNIVERSAL OPAQUE REFILL CHOICE 2 TRY-IN PASTE TRANSPARENT REFILL eCEMENT (Light-Cured) A1 eCEMENT (Light-Cured) Translucent eCEMENT (Light-Cured) Milky Bright eCEMENT (Dual-Cured) Dual-Syringe eCEMENT Adhesive Cementation System Kit eCEMENT Try-In Paste A1 eCEMENT Try-In Paste Milky Bright eCEMENT Try-In Paste Translucent BISCEM Translucent Dual Syringe Kit BISCEM Opaque Dual Syringe Kit Theracem self adhesive resin cement TheraCem THERACAL LC 4 SYRINGE PACKAGE THERACAL LC 1 SYRINGE PACKAGE
Model Identifier(s)
A-19030P A-19620K A-197MWP B-3110P C-3900K C-39010K C-411A1P C-411A2P C-411A3P C-411B1P C-411MBP C-411MOP C-411OPP C-411TRP C-412A1P C-412A2P C-412A3P C-412B1P C-412MBP C-412MOP C-412OPP C-412TRP C-52010P C-52120P C-52230P C-52340P C-52400K C-531A1P C-531MBP C-531TRP D-45011P D-45012P D-46302PS D-46311P H-33014P H-3301P