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510(k) K231087

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

K231087 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "Guided Surgery Kit". The FDA issued a decision of Substantially Equivalent on August 16, 2023. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Implant Direct Sybron Manufacturing, LLC has at least 10 other 510(k) clearances on record.

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

Other clearances by Implant Direct Sybron Manufacturing, LLC

  • K223535 — SMARTbase Abutment System (June 20, 2023)
  • K222211 — Implant Direct Dental Implant Systems Portfolio - MR Conditional (February 2, 2023)
  • K202524 — Standard Sterilizable Tray (January 28, 2021)
  • K201553 — Simply Iconic Implants (January 22, 2021)
  • K200858 — Mini Sterilizable Tray (August 6, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192221 — Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2 (June 25, 2020)
  • K192218 — Custom Legacy and Custom InterActive Titanium Abutments (May 8, 2020)
  • K191458 — Legacy SMARTBase Abutments (October 10, 2019)
  • K181359 — InterActive SMARTBase Abutments (August 15, 2018)

Other clearances for product code DZI

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • 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)

FDA data resources