Product Code: DZI FDA class 2 21 CFR 872.4120

Drill, Bone, Powered

Dental

The Powered Bone Drill is a dental and oral surgical device used to create holes or channels in bone during oral surgical and implant procedures, driven by a powered mechanism. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZI and the applicable regulation is 21 CFR 872.4120, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: DZI
Device Class: FDA class 2
Regulation Number: 872.4120
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

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 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253776	Implantmed Plus II & Piezomed Plus II Module	Jun 18, 2026	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K254163	VarioSurg 4	Dec 23, 2025	Substantially Equivalent	Nakanishi, Inc.
K242432	MT-Bone	Aug 19, 2024	Substantially Equivalent	Mectron S.P.A.
K240340	Surgical Drive System (Model: ES70, ES90, E8)	Jul 18, 2024	Substantially Equivalent	Guangdong Jinme Medical Technology Co., Ltd.
K231087	Guided Surgery Kit	Aug 16, 2023	Substantially Equivalent	Implant Direct Sybron Manufacturing, LLC
K192561	TRAUS SUS20	Jul 13, 2020	Substantially Equivalent	Saeshin Precision Co., Ltd.
K200265	Surgical Drills	Jun 30, 2020	Substantially Equivalent	Implant Direct Sybron Manufacturing, LLC
K192033	Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip	Jun 09, 2020	Substantially Equivalent	Bennett Jacoby, Dds, Ms, Inc.
K172137	PIEZOTOME CUBE	May 03, 2018	Substantially Equivalent	Satelec - Acteon Group
K171326	Piezosurgery White	Apr 13, 2018	Substantially Equivalent	Mectron S.P.A.
K171958	PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE	Jan 12, 2018	Substantially Equivalent	Mectron S.P.A.
K152125	Oral Surgery System and Accessories	Aug 15, 2016	Substantially Equivalent	Bonart Co., Ltd.
K151248	PIEZOSURGERY WHITE	Sep 04, 2015	Substantially Equivalent	Mectron S.P.A.
K151171	TRAUS SUS10	Sep 01, 2015	Substantially Equivalent	Saeshin Precision Co., Ltd.
K150076	Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L	Jun 02, 2015	Substantially Equivalent	Dong IL Technology , Ltd.
K133488	PIEZOMED	Oct 16, 2014	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K121620	ULTRASONIC SURGERY	Dec 11, 2012	Substantially Equivalent	Dmetec.Co., Ltd.
K122322	PIEZOSURGERY TOUCH	Dec 06, 2012	Substantially Equivalent	Mectron S.P.A.
K113152	ULTRASONIC SURGERY MACHINE	Jun 14, 2012	Substantially Equivalent	Dmetec.Co., Ltd.
K112188	PIEZOTOME SOLO	Feb 03, 2012	Substantially Equivalent	Satelec - Acteon, Inc.
K110881	ULTRASONIC SURGICAL UNIT	Dec 16, 2011	Substantially Equivalent	Dong IL Technology , Ltd.
K111290	PIEZO BONE SURGERY	Nov 18, 2011	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K091227	PIEZOSURGERY 3; OSSTEM PIEZO	Dec 29, 2009	Substantially Equivalent	Piezosurgery S.R.L.
K091331	PIEZOTOME 2	Dec 11, 2009	Substantially Equivalent	Satelec
K091252	IMPLANT CENTER 2	Jul 22, 2009	Substantially Equivalent	Satelec
K082649	SYNTHES 90 DEGREE SCREWDRIVER	Apr 30, 2009	Substantially Equivalent	Synthes (Usa)
K083569	SURGYBONE	Apr 01, 2009	Substantially Equivalent	Silfradent S.R.L.
K082532	STRAUMANN GUIDED INSTRUMENTS	Oct 21, 2008	Substantially Equivalent	Straumann USA
K080761	BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES	Aug 25, 2008	Substantially Equivalent	Bonart Co., Ltd.
K080220	PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE	Jul 28, 2008	Substantially Equivalent	Italia Medica S.R.L.
K073678	VARIOSURG	Jul 10, 2008	Substantially Equivalent	Nakanishi, Inc.
K072146	EMS PIEZON MASTER SURGERY	Dec 18, 2007	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K072030	IMPLANT CENTER	Nov 19, 2007	Substantially Equivalent	Satelec - Acteon Group
K060274	PIEZOTOME	May 01, 2006	Substantially Equivalent	Satelec
K060270	MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL	Apr 10, 2006	Substantially Equivalent	Linvatec Corp.
K043408	PIEZOSURGERY DEVICE	Jun 08, 2005	Substantially Equivalent	Piezosurgery S.R.L.
K042434	MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55	Nov 03, 2004	Substantially Equivalent	NOUVAG AG
K032607	POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185	Nov 10, 2003	Substantially Equivalent	Linvatec Corp.
K032117	STRYKER TOTAL PERFORMANCE (TPS) SYSTEM	Aug 08, 2003	Substantially Equivalent	Stryker Instruments
K991696	STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM	Oct 25, 1999	Substantially Equivalent	Stryker Instruments
K990846	AMORPHOUS DIAMOND COATED DRILL	Jun 10, 1999	Substantially Equivalent	Nobel Biocare Uas, Inc.
K954690	STRYKER ORAL MAX SYSTEM	Aug 20, 1996	Substantially Equivalent	Stryker Corp.
K874535	MICROTEK MINI-MAX DRILL SYSTEM	Nov 23, 1987	Substantially Equivalent	Microtek Medical, Inc.
K871648	TMJ CANNULA SET	Jun 08, 1987	Substantially Equivalent	Aspen Laboratories, Inc.
K803291	ARTUS DRILL #2000	Jan 28, 1981	Substantially Equivalent	Jedmed Instrument Co.
K803290	ARTUS DRILL #3000	Jan 28, 1981	Substantially Equivalent	Jedmed Instrument Co.
K803289	ARTUS DRILL #4000	Jan 28, 1981	Substantially Equivalent	Jedmed Instrument Co.
K803288	ARTUS DRILL #6000	Jan 28, 1981	Substantially Equivalent	Jedmed Instrument Co.
K791326	MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL	Oct 17, 1979	Substantially Equivalent	Sherwood Medical Co.