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510(k) K900089

FG DIAMOND BURRS by Kab Gloves Unltd. — Product Code DZP

K900089 is an FDA 510(k) premarket notification submitted by Kab Gloves Unltd. for the device "FG DIAMOND BURRS". The FDA issued a decision of Substantially Equivalent on April 3, 1990. The device falls under product code DZP (Instrument, Diamond, Dental), a Class I device regulated under 21 CFR 872.4535. Kab Gloves Unltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1990
Date Received
January 5, 1990
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 Kab Gloves Unltd.

  • K900135 — CU-75 VISIBLE LIGHT-CURING UNIT (May 7, 1990)
  • K900631 — SALIVA ABSORBER - DENTAL (April 4, 1990)
  • K900088 — MASKS SURGICAL DENTAL (March 8, 1990)

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)
  • K893844 — 3D DENTAL DIAMOND ROTARY INSTRUMENTS (August 11, 1989)
  • K885233 — NOVA DIAMOND (February 13, 1989)

FDA data resources