Singapore HSA registration DE0504337
BISCO Aelite Aesthetic Enamel
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
- Name
- Bisco Inc
- 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B