Ultrasonic Surgery Machine
510(k) K113152
Ultrasonic Surgery Machine is a medical device (FDA Class II; FDA product code DZI, Drill, Bone, Powered) made by Dmetec.Co., Ltd., cleared under FDA 510(k) K113152 on 14 Jun 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113152 | Date14 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K113152
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZI
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4120
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K113152
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SURGYSTAR G01 | G01 | 08809462190005 | — | On the market |
Similar devices
Other devices filed under FDA product code DZI (Drill, Bone, Powered).
- ULTRASONIC SURGICAL UNIT by Dong IL Technology, Ltd.
- Piezosurgery White by Mectron S.p.A.
- PIEZOSURGERY 3; OSSTEM PIEZO by Piezosurgery S.R.L.
- SILFRADENT srl SB P0500 by SILFRADENT SRL
- POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 by Linvatec Corp.
- SILFRADENT srl SB P0400 by SILFRADENT SRL
- ARTUS DRILL #6000 by JEDMED Instrument Company
- TRAUS SUS10 TRAUS CRB26LX by Saeshin Precision Co., Ltd.
- BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES by BONART CO., LTD.
- Piezomed Pro M-PH350 30501000 by W&H Dentalwerk Burmoos