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510(k) K871639

DENTAL DIAMOND BURS by E&D Dental Manufacturing Co. — Product Code DZP

K871639 is an FDA 510(k) premarket notification submitted by E&D Dental Manufacturing Co. for the device "DENTAL DIAMOND BURS". The FDA issued a decision of Substantially Equivalent on May 18, 1987. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. E&D Dental Manufacturing Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1987
Date Received
April 27, 1987
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 by E&D Dental Manufacturing Co.

  • K883698 — ZINC OXIDE EUGENOL TEMPORARY CEMENT (November 29, 1988)
  • K873739 — ACRYLIC IMPRESSION TRAY MATERIALS (March 7, 1988)
  • K873738 — ACRYLIC BASE DENTURE MATERIALS (November 20, 1987)
  • K864922 — DENTAL HANDPIECES AND ATTACHMENT (February 19, 1987)
  • K862745 — EUGENOL USP (July 31, 1986)

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)
  • 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)

FDA data resources