510(k) K991283

DYNA TORQ TORQUE WRENCH, TORQUE WRENCH by Micro Motors, Inc. — Product Code DZE

K991283 is an FDA 510(k) premarket notification submitted by Micro Motors, Inc. for the device "DYNA TORQ TORQUE WRENCH, TORQUE WRENCH". The FDA issued a decision of Substantially Equivalent on August 18, 1999. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Micro Motors, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1999
Date Received
April 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type