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510(k) K060270

MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL by Linvatec Corp. — Product Code DZI

K060270 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL". The FDA issued a decision of Substantially Equivalent on April 10, 2006. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Linvatec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2006
Date Received
February 1, 2006
Clearance Type
Special
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 Linvatec Corp.

  • K092998 — CONMED LINVATEC INTERCEPT IMPLANT (December 23, 2009)
  • K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM (June 23, 2009)
  • K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (June 22, 2009)
  • K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (April 10, 2009)
  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (February 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND (May 11, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (April 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (March 25, 2005)
  • K050227 — THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER (March 2, 2005)

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)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • 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)

FDA data resources