Singapore HSA registration DE0508352
Biolase Waterlase MDX Laser System
Singapore·CLASS C·Biolase, Inc.·Registered August 02, 2023Device 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 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.
Product Owner
- Name
- Biolase, Inc.
- Short Name
- Biolase, Inc.
- Address
- 27042 Towne Centre Drive, Foothill Ranch, CA 92610, UNITED STATES
Registrant
- Name
- Fondaco Pte Ltd
- Address
- 7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
- Name
- Fondaco Pte Ltd
- 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
About this record
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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