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510(k) K113152

ULTRASONIC SURGERY MACHINE by Dmetec.Co., Ltd. — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2012
Date Received
October 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Dmetec.Co., Ltd.

  • K170104 — COMPACT S, COMPACT S (LED) (December 27, 2017)
  • K121620 — ULTRASONIC SURGERY (December 11, 2012)
  • K060171 — CLEANSE S+ ULTRASONIC SCALER (March 29, 2006)
  • K051571 — SKYLIGHT LED CURING LIGHT (July 19, 2005)

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  • K231087 — Guided Surgery Kit (August 16, 2023)
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  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)