DZI · Class II · 21 CFR 872.4120

FDA Product Code DZI: Drill, Bone, Powered

Leading manufacturers include Mectron S.P.A., Jedmed Instrument Co. and Satelec.

50
Total
50
Cleared
154d
Avg days
1979
Since
Stable submission activity - 3 submissions in the last 2 years
Consistent review times: 153d avg (recent)

FDA 510(k) Cleared Drill, Bone, Powered Devices (Product Code DZI)

50 devices
1–24 of 50
Cleared Jul 31, 2026
Angled Screwdriver MED (M-SD090)
K253655
W&H Dentalwerk B?rmoos GmbH
Dental · 253d
Cleared Jun 18, 2026
Implantmed Plus II & Piezomed Plus II Module
K253776
W&H Dentalwerk Buermoos GmbH
Dental · 204d
Cleared Dec 23, 2025
VarioSurg 4
K254163
Nakanishi, Inc.
Dental · 1d
Cleared Aug 19, 2024
MT-Bone
K242432
Mectron S.P.A.
Dental · 3d
Cleared Jul 18, 2024
Surgical Drive System (Model: ES70, ES90, E8)
K240340
Guangdong Jinme Medical Technology Co., Ltd.
Dental · 164d
Cleared Aug 16, 2023
Guided Surgery Kit
K231087
Implant Direct Sybron Manufacturing, LLC
General Hospital · 121d
Cleared Jul 13, 2020
TRAUS SUS20
K192561
Saeshin Precision Co., Ltd.
Dental · 300d
Cleared Jun 30, 2020
Surgical Drills
K200265
Implant Direct Sybron Manufacturing, LLC
Dental · 148d
Cleared Jun 09, 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
K192033
Bennett Jacoby, Dds, Ms, Inc.
Dental · 315d
Cleared May 03, 2018
PIEZOTOME CUBE
K172137
Satelec - Acteon Group
Dental · 290d
Cleared Apr 13, 2018
Piezosurgery White
K171326
Mectron S.P.A.
Dental · 343d
Cleared Jan 12, 2018
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
K171958
Mectron S.P.A.
Dental · 197d
Cleared Aug 15, 2016
Oral Surgery System and Accessories
K152125
Bonart Co., Ltd.
Dental · 381d
Cleared Sep 04, 2015
PIEZOSURGERY WHITE
K151248
Mectron S.P.A.
Dental · 116d
Cleared Sep 01, 2015
TRAUS SUS10
K151171
Saeshin Precision Co., Ltd.
Dental · 123d
Cleared Jun 02, 2015
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
K150076
Dong IL Technology , Ltd.
Dental · 139d
Cleared Oct 16, 2014
PIEZOMED
K133488
W&H Dentalwerk Buermoos GmbH
Dental · 337d
Cleared Dec 11, 2012
ULTRASONIC SURGERY
K121620
Dmetec.Co., Ltd.
Dental · 193d
Cleared Dec 06, 2012
PIEZOSURGERY TOUCH
K122322
Mectron S.P.A.
Dental · 127d
Cleared Jun 14, 2012
ULTRASONIC SURGERY MACHINE
K113152
Dmetec.Co., Ltd.
Dental · 233d
Cleared Feb 03, 2012
PIEZOTOME SOLO
K112188
Satelec - Acteon, Inc.
Dental · 189d
Cleared Dec 16, 2011
ULTRASONIC SURGICAL UNIT
K110881
Dong IL Technology , Ltd.
Dental · 261d
Cleared Nov 18, 2011
PIEZO BONE SURGERY
K111290
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 196d
Cleared Dec 11, 2009
PIEZOTOME 2
K091331
Satelec
Dental · 220d

About Product Code DZI - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code DZI since 1979, with 50 receiving FDA clearance (average review time: 154 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - DZI Product Code

FDA review times for DZI submissions have been consistent, averaging 153 days recently vs 154 days historically.

DZI devices are reviewed by the Dental panel. Browse all Dental devices →