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510(k) K072273

BELMONT QUOLIS 5000 SERIES DENTAL UNIT by Takara Belmont USA, Inc. — Product Code NRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
August 15, 2007
Clearance Type
Traditional
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.

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Other clearances for product code NRD

  • K042266 — ACCLAIM (August 31, 2004)