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510(k) K060270

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

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

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  • 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)

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