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510(k) K862110

OSSEODENT DRILLING SYSTEM by Otc/America — Product Code KMW

K862110 is an FDA 510(k) premarket notification submitted by Otc/America for the device "OSSEODENT DRILLING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 1986. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Otc/America has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
June 3, 1986
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

Other clearances by Otc/America

  • K860653 — PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT (April 17, 1986)

Other clearances for product code KMW

  • K211584 — Oral Surgery Contra (August 19, 2021)
  • K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece (November 21, 2017)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (July 29, 2008)
  • 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)

FDA data resources