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FDA 510(k) Application Details - K213932
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K213932
Device Name
Unit, Operative Dental
Applicant
A-dec, Inc.
2601 Crestview Drive
Newberg, OR 97132 US
Other 510(k) Applications for this Company
Contact
Raquel Peregrino de Brito
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2021
Decision Date
03/02/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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