Singapore HSA registration DE0504337

BISCO Aelite Aesthetic Enamel

Singapore flagSingapore·CLASS B·Bisco Inc·Registered April 07, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0504337
Registration Date
April 07, 2020
Retention Due Date
April 06, 2026
Product description
The ÆLITE Enamel is a light-cured, fluorescing, highly reinforced, nanofil composite used for all classes of direct restorations as the enamel layer and for splinting periodontally involved teeth.
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)
AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel AElite Aesthetic Enamel
Model Identifier(s)
H-852A1P H-852A2P H-852A35P H-852A3P H-852A4P H-852B1P H-852B2P H-852B3P H-852B4P H-852C1P H-852C2P H-852C3P H-852C4P H-852D2P H-852D3P H-852D4P H-852W2P H-854A1P H-854A2P H-854A35P H-854A3P H-854A4P H-854B1P H-854B2P H-854B3P H-854B4P H-854C1P H-854C2P H-854C3P H-854C4P H-854D2P H-854D3P H-854D4P H-854W2P
About this record

Access comprehensive regulatory information for BISCO Aelite Aesthetic Enamel in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504337 and owned by Bisco Inc. The device was registered on April 07, 2020.

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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