FDA.report

510(k) K240801

Device
BioSonic US200 Ultrasonic Scaler (60034537)
Applicant
Dent4you AG
510(k) number
K240801
Product code
ELC
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-01
Date received
2024-03-25
Regulation
872.4850
Classification name
Scaler, Ultrasonic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tricia Cregger
Address
Bahnhofstrasse 2 Heerbrugg CH 9435 9435

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07630392909938US200Dent4You AG2024-07-31
07630392904353US200Dent4You AG2024-07-31
07630392909815US200Dent4You AG2024-07-31
07630392909839US200Dent4You AG2024-07-31
07630392909846US200Dent4You AG2024-07-31
07630392909853US200Dent4You AG2024-07-31
07630392909860US200Dent4You AG2024-07-31
07630392909877US200Dent4You AG2024-07-31
07630392909884US200Dent4You AG2024-07-31
07630392909891US200Dent4You AG2024-07-31
07630392909907US200Dent4You AG2024-07-31
07630392909914US200Dent4You AG2024-07-31
07630392909921US200Dent4You AG2024-07-31
07630392910064US200Dent4You AG2024-07-31
07630392909945US200Dent4You AG2024-07-31
07630392909952US200Dent4You AG2024-07-31
07630392909969US200Dent4You AG2024-07-31
07630392909976US200Dent4You AG2024-07-31
07630392909990US200Dent4You AG2024-07-31
07630392910002US200Dent4You AG2024-07-31
07630392910019US200Dent4You AG2024-07-31
07630392910026US200Dent4You AG2024-07-31
07630392910033US200Dent4You AG2024-07-31
07630392910040US200Dent4You AG2024-07-31
07630392910057US200Dent4You AG2024-07-31

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