FDA Product Code
FDA Product Code DZI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4120
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | 2026-07-31 | Traditional | PDF ↗ |
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | 2026-06-18 | Traditional | PDF ↗ |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 2025-12-23 | Traditional | PDF ↗ |
| K242432 | MT-Bone | Mectron S.P.A. | 2024-08-19 | Traditional | PDF ↗ |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-07-18 | Traditional | PDF ↗ |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | 2023-08-16 | Traditional | PDF ↗ |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | 2020-07-13 | Traditional | PDF ↗ |
| K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | 2020-06-30 | Traditional | PDF ↗ |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | Bennett Jacoby, Dds, Ms, Inc. | 2020-06-09 | Traditional | PDF ↗ |
| K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | 2018-05-03 | Traditional | PDF ↗ |
| K171326 | Piezosurgery White | Mectron S.P.A. | 2018-04-13 | Traditional | PDF ↗ |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | 2018-01-12 | Traditional | PDF ↗ |
| K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | 2016-08-15 | Traditional | PDF ↗ |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | 2015-09-04 | Traditional | PDF ↗ |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2015-09-01 | Traditional | PDF ↗ |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | 2015-06-02 | Traditional | PDF ↗ |
| K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH | 2014-10-16 | Traditional | PDF ↗ |
| K121620 | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | 2012-12-11 | Traditional | PDF ↗ |
| K122322 | PIEZOSURGERY TOUCH | Mectron S.P.A. | 2012-12-06 | Traditional | PDF ↗ |
| K113152 | ULTRASONIC SURGERY MACHINE | Dmetec.Co., Ltd. | 2012-06-14 | Traditional | PDF ↗ |
| K112188 | PIEZOTOME SOLO | Satelec - Acteon, Inc. | 2012-02-03 | Traditional | PDF ↗ |
| K110881 | ULTRASONIC SURGICAL UNIT | Dong IL Technology , Ltd. | 2011-12-16 | Traditional | PDF ↗ |
| K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | 2011-11-18 | Traditional | PDF ↗ |
| K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | 2009-12-29 | Traditional | PDF ↗ |
| K091331 | PIEZOTOME 2 | Satelec | 2009-12-11 | Traditional | PDF ↗ |
| K091252 | IMPLANT CENTER 2 | Satelec | 2009-07-22 | Traditional | PDF ↗ |
| K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | 2009-04-30 | Traditional | PDF ↗ |
| K083569 | SURGYBONE | Silfradent S.R.L. | 2009-04-01 | Abbreviated | PDF ↗ |
| K082532 | STRAUMANN GUIDED INSTRUMENTS | Straumann USA | 2008-10-21 | Traditional | PDF ↗ |
| K080761 | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES | Bonart Co., Ltd. | 2008-08-25 | Traditional | PDF ↗ |
| K080220 | PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE | Italia Medica S.R.L. | 2008-07-28 | Abbreviated | PDF ↗ |
| K073678 | VARIOSURG | Nakanishi, Inc. | 2008-07-10 | Traditional | PDF ↗ |
| K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | 2007-12-18 | Traditional | PDF ↗ |
| K072030 | IMPLANT CENTER | Satelec - Acteon Group | 2007-11-19 | Traditional | PDF ↗ |
| K060274 | PIEZOTOME | Satelec | 2006-05-01 | Traditional | PDF ↗ |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | Linvatec Corp. | 2006-04-10 | Special | PDF ↗ |
| K043408 | PIEZOSURGERY DEVICE | Piezosurgery S.R.L. | 2005-06-08 | Traditional | PDF ↗ |
| K042434 | MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 | NOUVAG AG | 2004-11-03 | Traditional | PDF ↗ |
| K032607 | POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003-11-10 | Traditional | PDF ↗ |
| K032117 | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM | Stryker Instruments | 2003-08-08 | Special | PDF ↗ |
| K991696 | STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM | Stryker Instruments | 1999-10-25 | Traditional | PDF ↗ |
| K990846 | AMORPHOUS DIAMOND COATED DRILL | Nobel Biocare Uas, Inc. | 1999-06-10 | Traditional | PDF ↗ |
| K954690 | STRYKER ORAL MAX SYSTEM | Stryker Corp. | 1996-08-20 | Traditional | PDF ↗ |
| K874535 | MICROTEK MINI-MAX DRILL SYSTEM | Microtek Medical, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K871648 | TMJ CANNULA SET | Aspen Laboratories, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K803289 | ARTUS DRILL #4000 | Jedmed Instrument Co. | 1981-01-28 | Traditional | PDF ↗ |
| K803290 | ARTUS DRILL #3000 | Jedmed Instrument Co. | 1981-01-28 | Traditional | PDF ↗ |
| K803291 | ARTUS DRILL #2000 | Jedmed Instrument Co. | 1981-01-28 | Traditional | PDF ↗ |
| K803288 | ARTUS DRILL #6000 | Jedmed Instrument Co. | 1981-01-28 | Traditional | PDF ↗ |
| K791326 | MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL | Sherwood Medical Co. | 1979-10-17 | Traditional | PDF ↗ |
Product code DZI · Class II · Dental. Data: openFDA.