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510(k) K083101

PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES by Sable Industries, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2009
Date Received
October 20, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Sable Industries, Inc.

  • K072554 — ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (November 14, 2007)
  • K863885 — SABLE BLADES (October 24, 1986)

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