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510(k) K943841

SOPHOS DENTAL DIAMOND by Sophos Technologic — Product Code DZP

K943841 is an FDA 510(k) premarket notification submitted by Sophos Technologic for the device "SOPHOS DENTAL DIAMOND". The FDA issued a decision of Substantially Equivalent on September 16, 1994. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1994
Date Received
August 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Diamond, Dental
Device Class
Class I
Regulation Number
872.4535
Review Panel
DE
Submission Type

Other clearances for product code DZP

  • K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED (April 20, 2012)
  • K940908 — DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (August 29, 1994)
  • K934981 — DENTAL DRILL (February 3, 1994)
  • K923757 — DENTAL DIAMOND DRILLS (March 16, 1993)
  • K913651 — MANI DIA-BURS (January 14, 1992)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K901262 — F.G. LASER (DENTAL BUR) (July 9, 1990)
  • K900089 — FG DIAMOND BURRS (April 3, 1990)
  • K893844 — 3D DENTAL DIAMOND ROTARY INSTRUMENTS (August 11, 1989)
  • K885233 — NOVA DIAMOND (February 13, 1989)

FDA data resources