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FDA 510(k) Application Details - K183337
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K183337
Device Name
Crown And Bridge, Temporary, Resin
Applicant
DMG Chemisch-Pharmazeutische Fabrik GmbH
Elbgaustrasse 248
Hamburg 22547 DE
Other 510(k) Applications for this Company
Contact
Sonja Toeppen
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
12/03/2018
Decision Date
05/29/2019
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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