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W&H Synea handpieces - HSA Registration DE0508750

Access comprehensive regulatory information for W&H Synea handpieces in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508750 and owned by W&H Dentalwerk Burmoos GmbH. The device was registered on December 12, 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 B
DE0508750
W&H Synea handpieces
HSA Registration Number: DE0508750
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Product Description

The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing and polishing of tooth and restoration surfaces.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508750
Registration Date
December 12, 2023
Change Notification Approval Date
July 10, 2024
Retention Due Date
December 11, 2025
Product Owner
Short Name
W&H Dentalwerk Burmoos GmbH
Address
Ignaz-Glaser-StraBe 53, 5111 Burmoos, AUSTRIA
Registrant
Address
100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model Information
Model Name(s)
WG-99 LT WG-99 A WG-56 LT WG-56 A WG-66 LT WG-66 A HG-43 A
Model Identifier(s)
30007000 30008000 30009000 30010000 30011000 30012000 30013000