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510(k) K231087

Guided Surgery Kit by Implant Direct Sybron Manufacturing, LLC — Product Code DZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2023
Date Received
April 17, 2023
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

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Other clearances for product code DZI

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  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • 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)
  • K152125 — Oral Surgery System and Accessories (August 15, 2016)