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510(k) K120037

BLUWHITE DIAMOND DENTAL BURS MODIFIED by Beavers Dental, Div. Sybron Canada, Ltd. — Product Code DZP

K120037 is an FDA 510(k) premarket notification submitted by Beavers Dental, Div. Sybron Canada, Ltd. for the device "BLUWHITE DIAMOND DENTAL BURS MODIFIED". The FDA issued a decision of Substantially Equivalent on April 20, 2012. 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
April 20, 2012
Date Received
January 5, 2012
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.

  • K880179 — BEAVERS' DENTAL DIAMOND INSTRUMENTS (March 9, 1988)
  • K863097 — CB BUR (August 26, 1986)

Other clearances for product code DZP

  • 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)
  • K885233 — NOVA DIAMOND (February 13, 1989)

FDA data resources