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Biolase Waterlase MDX Laser System - HSA Registration DE0508352

Access comprehensive regulatory information for Biolase Waterlase MDX Laser System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508352 and owned by Biolase, Inc.. The device was registered on August 02, 2023.

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 C
DE0508352
Biolase Waterlase MDX Laser System
HSA Registration Number: DE0508352
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Product Description

The Waterlase MDX device is intended to cut and remove hard and soft tissues within the oral cavity. Indication for use: • hard tissue procedures (for use on adults and pediatric patients); • root canal hard tissue procedures; • endodontic surgery (root amputation) procedures; • bone surgical procedures; • laser periodontal procedures • soft tissue indications including pulpal tissues (for use on adults and pediatric patients); • root canal disinfection.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508352
Registration Date
August 02, 2023
Retention Due Date
August 01, 2025
Product Owner
Short Name
Biolase, Inc.
Address
27042 Towne Centre Drive, Foothill Ranch, CA 92610, UNITED STATES
Registrant
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model Information
Model Name(s)
Waterlase MDX 450 Waterlase MDX 300
Model Identifier(s)
7200860-06 7200861-06