FG Diamond Burrs

FDA 510(k) K900089 · Kab Gloves Unltd.

Substantially Equivalent

510(k) numberK900089

Submission

Device name
FG Diamond Burrs
Applicant
Kab Gloves Unltd.
Berkley, MI, US
Received
January 5, 1990
Decision date
April 3, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DZP – Instrument, Diamond, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4535
Specialty
Dental

Other 510(k)s with product code DZP

510(k)DeviceApplicantDecision
K120037Bluwhite Diamond Dental Burs ModifiedDZP · Traditional Beavers Dental, Div. Sybron Canada, Ltd.04/20/2012SE
K943841Sophos Dental DiamondDZP · Traditional Sophos Technologic09/16/1994SE
K940908Dunhall/Omnii International Rotary Diamond BursDZP · Traditional Dunhall Pharmaceuticals, Inc.08/29/1994SE
K934981Dental DrillDZP · Traditional Eare Consulting Service02/03/1994SE
K923757Dental Diamond DrillsDZP · Traditional Alpha Industrializacao DE Metais Ltda.03/16/1993SE
K913651Mani Dia-BursDZP · Traditional The Lahr Consulting Group, Inc.01/14/1992SE
K901967Dendia Werk Burs and Cutting DiscsDZP · Traditional Micro-Aire Surgical Instruments, Inc.07/13/1990SE
K901262F.G. Laser (Dental Bur)DZP · Traditional Diamond Rotary and Carbide Intl.07/09/1990SE
K8938443D Dental Diamond Rotary InstrumentsDZP · Traditional Lustgarten Multi-Tech International, Inc.08/11/1989SE
K885233Nova DiamondDZP · Traditional Microcopy, Div. Neo-Flo, Inc.02/13/1989SE

More from Microcopy, Div. Neo-Flo, Inc.

510(k)DeviceDecision
K900135CU-75 Visible Light-Curing UnitEBZ · Traditional 05/07/1990SE
K900631Saliva Absorber - DentalDYN · Traditional 04/04/1990SE
K900088Masks Surgical DentalFXX · Traditional 03/08/1990SE

Questions and answers

When was FG Diamond Burrs cleared by the FDA?

FG Diamond Burrs (K900089) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 88 days after the submission was received.

What is the product code of K900089?

The FDA product code is DZP – Instrument, Diamond, Dental, a Class I (low risk) device regulated under 21 CFR 872.4535.