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510(k) K011179

DELDENT ULTRASONIC INSERTS by Deldent , Ltd. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2001
Date Received
April 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by Deldent , Ltd.

  • K014252 — JETSTREAM (February 19, 2002)
  • K014249 — JETPOLISHER (February 19, 2002)
  • K014245 — JETSONIC 2000 (January 29, 2002)
  • K014238 — DELSONIC 2000 (January 24, 2002)
  • K013969 — MINIBLASTER (January 10, 2002)

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