510(k) K042266

ACCLAIM by Air Techniques, Inc. — Product Code NRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2004
Date Received
August 23, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental, Accessories
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.