FDA.report

510(k) K231635

Device
A-Line Advanced
Applicant
Biocetec Co., Ltd.
510(k) number
K231635
Product code
NJM
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-06
Date received
2023-06-05
Regulation
872.5470
Classification name
Bracket, Ceramic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Related Records

Applicant Contact

Contact
Hee Sue Jin
Address
Rm.1001,1002, New T Castle, 108 Gasan Digital 2-Ro Geumcheon-Gu Seoul KR 08506 08506

FDA Registration Numbers

Source Documents

510(k) summary PDF

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