FDA 510(k) K240597, TERA HARZ CLEAR, by Graphy, Inc.
FDA 510(k) K240597, TERA HARZ CLEAR, by Graphy, Inc.
Device Classification Name: Aligner, Sequential
510(k) Number: K240597
Device Name: TERA HARZ CLEAR
Applicant: Graphy, Inc.
Regulation Number: 872.547
Classification Product Code: NXC
Date Received: 2024-03-04
Decision Date: 2024-03-05
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
510k Review Panel: Dental
Total number of pages: 828
Fully redacted pages: 660
Content pages: 168
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