Singapore HSA registration DE0509384
Kulzer GLUMA Desensitizer
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 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.
Product Owner
- Name
- Kulzer GmbH
- 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
About this record
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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