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BISCO Dental restorative/ repair materials - HSA Registration DE0009667

Access comprehensive regulatory information for BISCO Dental restorative/ repair materials in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009667 and owned by Bisco Inc. The device was registered on August 29, 2012.

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.

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CLASS B
DE0009667
BISCO Dental restorative/ repair materials
HSA Registration Number: DE0009667
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Product Description

A substance intended to fill dental cavities, seal pits and fissures, restore damaged dental tissues, or for inlays, onlays and veneering. It may include accessories that are used specifically with the materials. It does not include obturation of root canal

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0009667
Registration Date
August 29, 2012
Change Notification Approval Date
April 07, 2020
Retention Due Date
August 28, 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)
BISFIL 2B BISFIL 2B BISFIL 2B BISFIL 2B LIGHT-CORE LIGHT-CORE LIGHT-CORE LIGHT-CORE LIGHT-CORE OPAQUER OPAQUER Reveal Reveal Reveal LIGHT-CORE Fortify Fortify Biscover LV Biscover LV Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite LS Posterior Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite All-Purpose Body Aelite LS Posterior Aelite Anterior AElite Aesthetic Incisal AElite Aesthetic Incisal AElite Aesthetic Incisal AElite Aesthetic Incisal AElite Aesthetic Incisal AElite Aesthetic Incisal Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain Characterization Stain
Model Identifier(s)
A-1254P A-1264K A-12710P A-12810P A-1725P A-1727P A-1728P A-1729P A-1750B B-2112Q B-2122Q C-461A12P C-461A22P C-462BL2P G-91730K G-9300F G-9301F G-93353P G-9335P H-72010K H-72020K H-72110K H-721A1P H-721A2P H-721A35P H-721A3P H-721B1P H-721C2P H-721C4P H-721D3P H-722A1P H-722A2P H-722A35P H-722A3P H-722B1P H-722C2P H-722C4P H-722D3P H-722PS1 H-803A2PS H-804A2PS H-81210K H-812A1OP H-812A1P H-812A2P H-812A35OP H-812A35P H-812A3P H-812B1P H-812C2P H-812D3P H-814A1OP H-814A1P H-814A2P H-814A35OP H-814A35P H-814A3P H-814B1P H-814C2P H-814D3P H-83240K H-85240K H-852CLP H-852FRP H-852LGP H-854CLP H-854FRP H-854LGP T-14012P T-14014P T-14015P T-14016P T-14017P T-14018P T-14019P T-14021P T-15003P T-15004P T-15006P T-15007P T-15008P T-15009P T-15010P