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FDA 510(k) Application Details - K002620
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K002620
Device Name
Unit, Operative Dental
Applicant
ORA METRIX, INC.
12740 HILLCREST ROAD, STE 100
DALLAS, TX 75230 US
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Contact
NANCY BUTCHER
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
08/23/2000
Decision Date
11/16/2000
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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