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Kulzer GLUMA Desensitizer - HSA Registration DE0509384

Access comprehensive regulatory information for Kulzer GLUMA Desensitizer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509384 and owned by Kulzer GmbH. The device was registered on June 12, 2024.

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
DE0509384
Kulzer GLUMA Desensitizer
HSA Registration Number: DE0509384
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Product Description

GLUMA Desensitizer is used for the treatment of hypersensitive dentine. It achieves its effects by precipitation of plasma proteins, which reduces dentinal permeability and occludes the peripheral dentinal tubules. This inhibits the flow of fluid through the tubules which is the cause of sensitivity. This dental material is suitable for patients requiring dental treatment for the following indications with consideration of the contraindications. For pregnant and nursing women, the treatment risks must be weighed carefully against the benefits taking into consideration the unborn child or infant. Kulzer medical devices ensure the rehabilitation of oral functions such as chewing, speaking and aesthetics. They stabilize the remaining dentition and/or the alveolar ridge restoratively or prosthetically or they aid in the rehabilitation process.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509384
Registration Date
June 12, 2024
Retention Due Date
June 11, 2025
Product Owner
Short Name
Kulzer GmbH
Address
Leipziger Strasse 2, 63450 Hanau, GERMANY
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
68 CIRCULAR ROAD, #02-01, SINGAPORE 049422 9 RAFFLES PLACE, REPUBLIC PLAZA, #26-01, SINGAPORE 048619
Model Information
Model Name(s)
GLUMA Desensitizer
Model Identifier(s)
66003764