Atlas FDA

DZI

50 FDA 510(k) clearances · Product code

148 daysmedian time to decision
314 days90th percentile
50clearances measured

FDA profile

Official device name
Drill, Bone, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 84 · 2022: 63 · 2023: 63 · 2024: 58 · 2025: 40 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Angled Screwdriver MED (M-SD090) (K253655)W&H Dentalwerk Bürmoos GmbH2026-07-31
Implantmed Plus II & Piezomed Plus II Module (K253776)W&H Dentalwerk Buermoos GmbH2026-06-18
VarioSurg 4 (K254163)Nakanishi, Inc.2025-12-23
MT-Bone (K242432)Mectron S.P.A.2024-08-19
Surgical Drive System (Model: ES70, ES90, E8) (K240340)Guangdong Jinme Medical Technology Co., Ltd.2024-07-18
Guided Surgery Kit (K231087)Implant Direct Sybron Manufacturing, LLC2023-08-16
TRAUS SUS20 (K192561)Saeshin Precision Co., Ltd.2020-07-13
Surgical Drills (K200265)Implant Direct Sybron Manufacturing, LLC2020-06-30
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.2020-06-09
PIEZOTOME CUBE (K172137)Satelec - Acteon Group2018-05-03
Piezosurgery White (K171326)Mectron S.P.A.2018-04-13
PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (K171958)Mectron S.P.A.2018-01-12
Oral Surgery System and Accessories (K152125)Bonart Co., Ltd.2016-08-15
PIEZOSURGERY WHITE (K151248)Mectron S.P.A.2015-09-04
TRAUS SUS10 (K151171)Saeshin Precision Co., Ltd.2015-09-01
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (K150076)Dong IL Technology , Ltd.2015-06-02
PIEZOMED (K133488)W&H Dentalwerk Buermoos GmbH2014-10-16
ULTRASONIC SURGERY (K121620)Dmetec.Co., Ltd.2012-12-11
PIEZOSURGERY TOUCH (K122322)Mectron S.P.A.2012-12-06
ULTRASONIC SURGERY MACHINE (K113152)Dmetec.Co., Ltd.2012-06-14
PIEZOTOME SOLO (K112188)Satelec - Acteon, Inc.2012-02-03
ULTRASONIC SURGICAL UNIT (K110881)Dong IL Technology , Ltd.2011-12-16
PIEZO BONE SURGERY (K111290)Guilin Woodpecker Medical Instrument Co., Ltd.2011-11-18
PIEZOSURGERY 3; OSSTEM PIEZO (K091227)Piezosurgery S.R.L.2009-12-29
PIEZOTOME 2 (K091331)Satelec2009-12-11
IMPLANT CENTER 2 (K091252)Satelec2009-07-22
SYNTHES 90 DEGREE SCREWDRIVER (K082649)Synthes (Usa)2009-04-30
SURGYBONE (K083569)Silfradent S.R.L.2009-04-01
STRAUMANN GUIDED INSTRUMENTS (K082532)Straumann USA2008-10-21
BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES (K080761)Bonart Co., Ltd.2008-08-25
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE (K080220)Italia Medica S.R.L.2008-07-28
VARIOSURG (K073678)Nakanishi, Inc.2008-07-10
EMS PIEZON MASTER SURGERY (K072146)E.M.S Electro Medical Systems S.A2007-12-18
IMPLANT CENTER (K072030)Satelec - Acteon Group2007-11-19
PIEZOTOME (K060274)Satelec2006-05-01
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (K060270)Linvatec Corp.2006-04-10
PIEZOSURGERY DEVICE (K043408)Piezosurgery S.R.L.2005-06-08
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (K042434)NOUVAG AG2004-11-03
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 (K032607)Linvatec Corp.2003-11-10
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM (K032117)Stryker Instruments2003-08-08
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM (K991696)Stryker Instruments1999-10-25
AMORPHOUS DIAMOND COATED DRILL (K990846)Nobel Biocare Uas, Inc.1999-06-10
STRYKER ORAL MAX SYSTEM (K954690)Stryker Corp.1996-08-20
MICROTEK MINI-MAX DRILL SYSTEM (K874535)Microtek Medical, Inc.1987-11-23
TMJ CANNULA SET (K871648)Aspen Laboratories, Inc.1987-06-08
ARTUS DRILL #4000 (K803289)Jedmed Instrument Co.1981-01-28
ARTUS DRILL #6000 (K803288)Jedmed Instrument Co.1981-01-28
ARTUS DRILL #3000 (K803290)Jedmed Instrument Co.1981-01-28
ARTUS DRILL #2000 (K803291)Jedmed Instrument Co.1981-01-28
MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL (K791326)Sherwood Medical Co.1979-10-17

Track DZI automatically

Every clearance here is in the API, with alerts when new ones post.