DZI · Class II · 21 CFR 872.4120

FDA Product Code DZI: Drill, Bone, Powered

Leading manufacturers include Jedmed Instrument Co., Mectron S.P.A. and Implant Direct Sybron Manufacturing, LLC.

50
Total
50
Cleared
154d
Avg days
1979
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 115d recently vs 158d historically

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

50 devices
1–24 of 50
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 Apr 30, 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649
Synthes (Usa)
Dental · 230d
Cleared Oct 21, 2008
STRAUMANN GUIDED INSTRUMENTS
K082532
Straumann USA
Dental · 49d
Cleared Jul 10, 2008
VARIOSURG
K073678
Nakanishi, Inc.
Dental · 195d
Cleared Apr 10, 2006
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270
Linvatec Corp.
Dental · 68d
Cleared Nov 10, 2003
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607
Linvatec Corp.
Dental · 77d
Cleared Aug 08, 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117
Stryker Instruments
Dental · 30d
Cleared Oct 25, 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991696
Stryker Instruments
Dental · 160d
Cleared Aug 20, 1996
STRYKER ORAL MAX SYSTEM
K954690
Stryker Corp.
Dental · 314d
Cleared Jun 08, 1987
TMJ CANNULA SET
K871648
Aspen Laboratories, Inc.
Dental · 41d
Cleared Jan 28, 1981
ARTUS DRILL #6000
K803288
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #4000
K803289
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #3000
K803290
Jedmed Instrument Co.
Dental · 29d
Cleared Jan 28, 1981
ARTUS DRILL #2000
K803291
Jedmed Instrument Co.
Dental · 29d
Cleared Oct 17, 1979
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL
K791326
Sherwood Medical Co.
Dental · 97d

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 increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DZI Product Code

Recent submissions under DZI have taken an average of 115 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.

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