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510(k) K880179

BEAVERS' DENTAL DIAMOND INSTRUMENTS by Beavers Dental, Div. Sybron Canada, Ltd. — Product Code DZP

K880179 is an FDA 510(k) premarket notification submitted by Beavers Dental, Div. Sybron Canada, Ltd. for the device "BEAVERS' DENTAL DIAMOND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on March 9, 1988. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Beavers Dental, Div. Sybron Canada, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1988
Date Received
January 13, 1988
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 Beavers Dental, Div. Sybron Canada, Ltd.

  • K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED (April 20, 2012)
  • K863097 — CB BUR (August 26, 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