Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device
510(k) K080220
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080220 | Date28 Jul 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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
Overview
AI-generated summary, 1 Oct 2026
This device is a piezoelectric ultrasonic surgical instrument designed for precise bone cutting and debridement in dental procedures. It operates using ultrasonic vibrations to reshape or remove bone tissue with minimal trauma to surrounding structures, including soft tissue and nerves. The technology leverages high-frequency oscillations to achieve controlled osteotomy, sinus lift augmentation, or periodontal surgery without excessive heat generation. Its application is limited to dental specialties, where precision and safety are critical in procedures such as implant site preparation or cyst removal.
The device is supplied as a reusable medical instrument, intended for use in sterile operating environments such as dental clinics or oral surgery centers. It is classified under FDA regulation 872.4120 as a Class II powered bone drill, with an FDA 510(k) clearance for dental applications. No specific MRI safety classification is noted, and its use requires adherence to standard infection control protocols. The device is distributed under the product code DZI and is regulated under the Dental (DE) review panel.
Questions
AI-generated answers, 1 Oct 2026
What is the PIEZO Ultrasonic Bone Surgery Device used for?
The PIEZO Ultrasonic Bone Surgery Device is designed specifically for dental procedures, utilizing ultrasonic vibrations to perform precise bone cutting and debridement. It is ideal for tasks such as osteotomy, sinus lift augmentation, and periodontal surgery, where controlled bone reshaping or removal is required without causing excessive heat or damage to surrounding structures like soft tissue and nerves.
Is the PIEZO Ultrasonic Bone Surgery Device single-use or reusable?
The PIEZO Ultrasonic Bone Surgery Device is a reusable medical instrument. It is intended for use in sterile operating environments, such as dental clinics or oral surgery centers, and must adhere to standard infection control protocols to ensure safety and sterility between uses.
What regulatory approvals does this device hold?
This device holds an FDA 510(k) clearance, specifically for dental applications. It is classified under FDA regulation 872.4120 as a Class II powered bone drill and is regulated under the Dental (DE) review panel. The clearance type is abbreviated, indicating it is substantially equivalent to a predicate device.
How should the PIEZO Ultrasonic Bone Surgery Device be stored?
While the provided data does not specify storage conditions in detail, reusable medical devices like this one should be stored in a clean, dry environment, protected from dust, moisture, and direct sunlight. After use, the device must undergo proper cleaning, disinfection, and sterilization procedures to maintain its functionality and ensure patient safety. Always follow manufacturer guidelines for storage and maintenance.
Is there any specific MRI safety information for this device?
The provided information does not mention any specific MRI safety classification for the PIEZO Ultrasonic Bone Surgery Device. If MRI compatibility is a concern, it is essential to consult the manufacturer’s instructions or documentation for detailed guidance, as improper use near MRI machines can pose risks.