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FDA 510(k) Application Details - K192412
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K192412
Device Name
Handpiece, Air-Powered, Dental
Applicant
DentalEZ, Inc.
1816 Colonial Village Lane
Lancaster, PA 17601 US
Other 510(k) Applications for this Company
Contact
Robert Young
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2019
Decision Date
01/06/2020
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
N
Expedited Review
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