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510(k) K994298

FRIOS MICROSAW by Friadent GmbH — Product Code KMW

K994298 is an FDA 510(k) premarket notification submitted by Friadent GmbH for the device "FRIOS MICROSAW". The FDA issued a decision of Substantially Equivalent on February 18, 2000. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Friadent GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
December 21, 1999
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 Friadent GmbH

  • K040170 — FRIADENT PLUS DENTAL IMPLANT SYSTEMS (October 27, 2004)
  • K041509 — ANKYLOS DENTAL IMPLANT SYSTEM (August 26, 2004)
  • K040946 — ANKYLOS DENTAL IMPLANT SYSTEM (July 1, 2004)
  • K032302 — XIVE TG ABUTMENTS (October 2, 2003)
  • K032158 — XIVE DENTAL IMPLANT SYSTEM MULTIPLE (August 14, 2003)
  • K031674 — MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM (August 14, 2003)
  • K032284 — XIVE TG DENTAL IMPLANT SYSTEM (August 14, 2003)
  • K024004 — XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM (March 3, 2003)
  • K023799 — FRIOS ALGIPORE (February 5, 2003)
  • K021318 — XIVE DENTAL IMPLANT SYSTEM (July 2, 2002)

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)
  • 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)

FDA data resources