Home / 510(k) Clearances / K923757

510(k) K923757

DENTAL DIAMOND DRILLS by Alpha Industrializacao DE Metais Ltda. — Product Code DZP

K923757 is an FDA 510(k) premarket notification submitted by Alpha Industrializacao DE Metais Ltda. for the device "DENTAL DIAMOND DRILLS". The FDA issued a decision of Substantially Equivalent on March 16, 1993. 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
March 16, 1993
Date Received
July 28, 1992
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)
  • K940908 — DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS (August 29, 1994)
  • K934981 — DENTAL DRILL (February 3, 1994)
  • 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