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FDA 510(k) Application Details - K994172
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K994172
Device Name
Material, Impression
Applicant
SIRONA DENTAL SYSTEMS GMBH
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760-4153 US
Other 510(k) Applications for this Company
Contact
SHEILA HEMEON-HEYER
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/1999
Decision Date
02/08/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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