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510(k) K211584

Oral Surgery Contra by Nakanishi, Inc. — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2021
Date Received
May 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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Other clearances for product code KMW

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  • K994298 — FRIOS MICROSAW (February 18, 2000)
  • K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES (June 27, 1997)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K932255 — YOUNG D'GRANULATOR (April 15, 1994)
  • K862110 — OSSEODENT DRILLING SYSTEM (August 7, 1986)