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Kulzer GLUMA Dental Adhesives/Primers - HSA Registration DE0509373

Access comprehensive regulatory information for Kulzer GLUMA Dental Adhesives/Primers in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509373 and owned by Kulzer GmbH. The device was registered on June 10, 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
DE0509373
Kulzer GLUMA Dental Adhesives/Primers
HSA Registration Number: DE0509373
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Product Description

A material used as a bonding promoting substance between dental materials. It does not include cements.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509373
Registration Date
June 10, 2024
Retention Due Date
June 09, 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
Model Information
Model Name(s)
GLUMA Etch 35 Gel GLUMA Bond 5 GLUMA Bond Universal Bottle Refill GLUMA Bond Universal Bottle Value Pack GLUMA Ceramic Primer Bottle Refill GLUMA Bond Universal
Model Identifier(s)
66000130 66057341 66061421 66061422 66061425 66064741