Singapore HSA registration DE0017353
BIOLASE EPIC LASER SYSTEM
Singapore·CLASS C·Biolase, Inc.·Registered July 27, 2015Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0017353
- Registration Date
- July 27, 2015
- Change Notification Approval Date
- November 05, 2024
- Retention Due Date
- July 26, 2025
Product description
EPIC 10 intended to use on Dental Soft Tissue Indications, Laser Periodontal Procedures, Whitening and Pain Relief. Use of the EPIC device may be appropriate for incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter- dental gingival and epithelial lining of free gingiva.
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)
- Power Cord with Power Supply Wireless Footswitch Deep-Tissue Handpiece Surgical Handpiece E2 ezTip Endo Kit E4-4/ezTip Surgical E3-4/ezTip Surgical E2-4/ezTip Surgical E4/ezTip Perio E3/ezTip Perio E2/ezTip Endo Whitening/Contour Handpiece Epic 10 Laser System Epic Q Laser System
- Model Identifier(s)
- 2400129 6400146 6400311 6400479 7400015 7400016 7400017 7400018 7400019 7400020 7400021 7400022 7400042 7410008
About this record
Access comprehensive regulatory information for BIOLASE EPIC 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 DE0017353 and owned by Biolase, Inc.. The device was registered on July 27, 2015.
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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