510(k) K834072

INSTRUMENT, DENTAL by Venture Technology, Inc. — Product Code EMS

K834072 is an FDA 510(k) premarket notification submitted by Venture Technology, Inc. for the device "INSTRUMENT, DENTAL". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code EMS (Curette, Periodontic), a Class I device regulated under 21 CFR 872.4565. Venture Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
November 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Periodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type