Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device |
510(K) Number |
K222414 |
Device Name |
Resin, Denture, Relining, Repairing, Rebasing |
Applicant |
Graphy Inc.
603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro,
Geumcheon-gu,
Seoul 08503 KR
Other 510(k) Applications for this Company
|
Contact |
Tae-woo Kim
Other 510(k) Applications for this Contact |
Regulation Number |
872.3760
More FDA Info for this Regulation Number |
Classification Product Code |
EBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/10/2022 |
Decision Date |
08/11/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
DE - Dental |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|