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510(k) K070001

MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE by Mti Precision Products — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2007
Date Received
January 3, 2007
Clearance Type
Special
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 Mti Precision Products

  • K960541 — LYNX DPA DISPOSABLE PROPHY ANGLE (March 28, 1996)
  • K940261 — LYNX LOW-SPEED HANDPIECE (December 29, 1994)
  • K901488 — LYNX-SM, SCLAER DENTAL HANDPIECE (May 15, 1990)
  • K895736 — LYNX-HIGH SPEED HANDPIECE (December 18, 1989)

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