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FDA 510(k) Application Details - K241226
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K241226
Device Name
Crown And Bridge, Temporary, Resin
Applicant
Dreve Denatmid GmbH
Max-Planck-Strasse 31
59423 Unna
Nordrhein-Westfalen DE
Other 510(k) Applications for this Company
Contact
Anke Hⁿttenbrauck
Other 510(k) Applications for this Contact
Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2024
Decision Date
05/31/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241226
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