Dental Diamond Drills

FDA 510(k) K923757 · Alpha Industrializacao DE Metais Ltda.

Substantially Equivalent

510(k) numberK923757

Submission

Device name
Dental Diamond Drills
Applicant
Alpha Industrializacao DE Metais Ltda.
Taboso De Serra Brazil, BR
Received
July 28, 1992
Decision date
March 16, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K900089FG Diamond BurrsDZP · Traditional Kab Gloves Unltd.04/03/1990SE
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

Questions and answers

When was Dental Diamond Drills cleared by the FDA?

Dental Diamond Drills (K923757) received a 510(k) decision of Substantially Equivalent on March 16, 1993, 231 days after the submission was received.

What is the product code of K923757?

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