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W&H Dental scaling system, ultrasonic - HSA Registration DE0507310

Access comprehensive regulatory information for W&H Dental scaling system, ultrasonic in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507310 and owned by W&H Dentalwerk Burmoos GmbH. The device was registered on September 27, 2022.

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
DE0507310
W&H Dental scaling system, ultrasonic
HSA Registration Number: DE0507310
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Product Description

An assembly of devices that uses ultrasonic energy at its point of patient contact to remove accretions from tooth surfaces during dental cleaning or periodontal (gum) therapy. This device is used for procedures that may involve the removal of plaque, biofilm, or gross calculus from shallow to deep periodontal pockets. It can be also used for the removal of orthodontic cement.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507310
Registration Date
September 27, 2022
Retention Due Date
September 26, 2026
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)
foot control KPL C-NF tip 1U with tip changer tip 2U with tip changer tip 3U with tip changer tip 1P with tip changer tip 1I with tip changer tip 3PR with tip changer tip 3PL with tip changer tip 2E with wrench tip 3E with wrench tip 2R with tip changer tip 3RM with tip changer tip 3RD with tip changer tip 4E with wrench tip 5E with tip changer tip 6E with wrench tip 5P with tip changer tip 5Pl with tip changer tip 5Pr with tip changer tip 4P with tip changer tip 1UQ with tip changer tip 2UQ with tip changer tip 3UQ with tip changer tip 1PQ with tip changer tip 3PrQ with tip changer tip 3PIQ with tip changer tip 4PQ with tip changer tip 5PrQ with tip changer tip 5PIQ with tip changer tip 5PQ with tip changer tip 1IQ with tip changer C-NW PB-510 PB-520 PB-530 PB-5 L PB-5 L Q Set 90000253 Set 90000254 Set 90000255 Set 90000257 Set 90000258 Sets : 90000256
Model Identifier(s)
4717300 5076200 5076300 5368200 5370400 6364500 6364900 6365000 6368000 6368100 6368400 6368500 6368600 7812300 7812400 7812500 7965600 7965620 7965660 7965670 8023920 8023930 8023940 8023950 8023960 8023980 8024010 8024020 8024030 8024040 8024050 30316000 30323000 30324000 30325000 30326000 30327000 Set 90000253 Set 90000254 Set 90000255 Set 90000257 Set 90000258 Sets : 90000256