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FDA 510(k) Application Details - K984508
Device Classification Name
Drill, Dental, Intraoral
More FDA Info for this Device
510(K) Number
K984508
Device Name
Drill, Dental, Intraoral
Applicant
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLASER-STRASSE
A-5111
BUERMOOS 5111 AT
Other 510(k) Applications for this Company
Contact
HERBERT TRASCHWANDTNER
Other 510(k) Applications for this Contact
Regulation Number
872.4130
More FDA Info for this Regulation Number
Classification Product Code
DZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/1998
Decision Date
06/25/1999
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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