510(k) K171958
- Device
- PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
- Applicant
- Mectron SPA
- 510(k) number
- K171958
- Product code
- DZI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-12
- Date received
- 2017-06-29
- Regulation
- 872.4120
- Classification name
- Drill, Bone, Powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Franco Zunino
- Address
- Via Loreto 15 Carasco IT 16042 16042
FDA Registration Numbers#
- 8030987
- 2029275
- 2243757
- 9611993
- 9710363
- 3006540014
- 3001617766
- 3010287737
- 3033509898
- 3012607373
- 3007997036
- 3003933619
- 9680741
- 3008693672
- 3008868758
- 3007279848
- 3009756327
- 3010363503
- 8043792
- 3007689689
- 3014479313
- 3005282635
- 3008812560
- 1045834
- 3007031098
- 3000270450
- 8010468
- 3038718579
- 8044015
- 3009417901
- 3015440604
- 3012336822
- 3011300255
- 3005581016
- 1828288
- 3023852420
- 9613348
- 2027755
- 3025603301
- 1017294
- 3005031178
- 3015876273
- 3015967359
- 9614404
- 1422375
- 1648564
- 3002808022
- 3008534770
- 3013298431
- 2648666
- 3015212339
- 3005972890
- 3027339887
- 3017125161
- 9614438
- 9611253
- 2127132
- 2032098
- 3007958831
- 3036756245
- 3004464325
- 1054713
- 1419489
- 9681479
- 3017521423
- 8030965
- 3005344591
- 9611992
- 3002806603
- 3014683120
- 3010375018
- 3008910197
- 3007607709
- 1722638
- 3015882686
- 3015399803
- 3005497913
- 3034676720
Source Documents#
Other 510(k) Records For Product Code DZI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 2025-12-23 |
| K242432 | MT-Bone | Mectron S.P.A. | 2024-08-19 |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-07-18 |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | 2023-08-16 |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | 2020-07-13 |
| K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | 2020-06-30 |
| 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 |
| K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | 2018-05-03 |
| K171326 | Piezosurgery White | Mectron S.P.A. | 2018-04-13 |
| K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | 2016-08-15 |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | 2015-09-04 |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2015-09-01 |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | 2015-06-02 |
| K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH | 2014-10-16 |
| K121620 | ULTRASONIC SURGERY | Dmetec.Co., Ltd. | 2012-12-11 |
Legacy Summary#
summary
FDA Review#
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