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FDA 510(k), K193622, TRIOCLEAR System
FDA 510(k), K193622, TRIOCLEAR System
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$49.00 USD
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$49.00 USD
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per
510(K) Number: K193622
Device Name: TRIOCLEAR System
Manufacturer: Alwin Ngai
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: KXA
Date Received: 12/26/2019
Decision Date: 07/06/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: TRIOCLEAR System
Manufacturer: Alwin Ngai
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: KXA
Date Received: 12/26/2019
Decision Date: 07/06/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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