Product Code: DZP FDA class 1 21 CFR 872.4535

Instrument, Diamond, Dental

Dental

The Diamond Dental Instrument is a dental cutting tool with an abrasive diamond-coated surface, used in powered handpieces to cut, shape, and finish tooth structure and restorative materials during dental treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZP and the applicable regulation is 21 CFR 872.4535, under the Dental medical specialty.

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510(k)s

FEI Numbers

114

Registration Numbers

114

Unique Applicants

Years Active

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Basic Information

Product Code: DZP
Device Class: FDA class 1
Regulation Number: 872.4535
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K120037	BLUWHITE DIAMOND DENTAL BURS MODIFIED	Apr 20, 2012	Substantially Equivalent	Beavers Dental, Div. Sybron Canada, Ltd.
K943841	SOPHOS DENTAL DIAMOND	Sep 16, 1994	Substantially Equivalent	Sophos Technologic
K940908	DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS	Aug 29, 1994	Substantially Equivalent	Dunhall Pharmaceuticals, Inc.
K934981	DENTAL DRILL	Feb 03, 1994	Substantially Equivalent	Eare Consulting Service
K923757	DENTAL DIAMOND DRILLS	Mar 16, 1993	Substantially Equivalent	Alpha Industrializacao DE Metais Ltda.
K913651	MANI DIA-BURS	Jan 14, 1992	Substantially Equivalent	The Lahr Consulting Group, Inc.
K901967	DENDIA WERK BURS AND CUTTING DISCS	Jul 13, 1990	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K901262	F.G. LASER (DENTAL BUR)	Jul 09, 1990	Substantially Equivalent	Diamond Rotary and Carbide Intl.
K900089	FG DIAMOND BURRS	Apr 03, 1990	Substantially Equivalent	Kab Gloves Unltd.
K893844	3D DENTAL DIAMOND ROTARY INSTRUMENTS	Aug 11, 1989	Substantially Equivalent	Lustgarten Multi-Tech International, Inc.
K885233	NOVA DIAMOND	Feb 13, 1989	Substantially Equivalent	Microcopy, Div. Neo-Flo, Inc.
K880179	BEAVERS' DENTAL DIAMOND INSTRUMENTS	Mar 09, 1988	Substantially Equivalent	Beavers Dental, Div. Sybron Canada, Ltd.
K871639	DENTAL DIAMOND BURS	May 18, 1987	Substantially Equivalent	E&D Dental Manufacturing Co.
K854347	HYBRID POINTS	Dec 27, 1985	Substantially Equivalent	Shofu Dental Corp.
K833038	SUMMA DISK	Oct 04, 1983	Substantially Equivalent	Shofu Dental Corp.
K832856	GINGI CURETTAGE DIAMOND POINTS	Oct 04, 1983	Substantially Equivalent	Shofu Dental Corp.
K832855	TPE DIAMOND POINTS	Sep 29, 1983	Substantially Equivalent	Shofu Dental Corp.
K802987	JOTA DIAMOND DENTAL BURS	Dec 30, 1980	Substantially Equivalent	Swiss American Metal Craft Corp.
K802984	MEISINGER DIAMOND DENTAL BURS	Dec 30, 1980	Substantially Equivalent	Swiss American Metal Craft Corp.
K780864	DIAMOND STONES	Jun 14, 1978	Substantially Equivalent	Venture Technology, Inc.
K760987	DIAMOND STONES	Nov 15, 1976	Substantially Equivalent	Adp Intl., Inc.