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510(k) K940908

DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS by Dunhall Pharmaceuticals, Inc. — Product Code DZP

K940908 is an FDA 510(k) premarket notification submitted by Dunhall Pharmaceuticals, Inc. for the device "DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS". The FDA issued a decision of Substantially Equivalent on August 29, 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
August 29, 1994
Date Received
February 24, 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)
  • K943841 — SOPHOS DENTAL DIAMOND (September 16, 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