Piezo Bone Surgery
by Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) K111290
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK111290 | Date18 Nov 2011 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The Piezo Bone Surgery System is a powered, precision bone-cutting device designed for dental applications. It employs piezoelectric technology to oscillate at ultrasonic frequencies, enabling controlled bone resection with minimal trauma to surrounding tissues, soft tissue, and nerves. This distinguishes it from traditional rotary drills by reducing heat generation and collateral damage during surgical procedures.
This system is intended for use in dental offices and oral surgery settings, supplied as a reusable medical device. It is not sterile upon receipt and requires sterilization before use, adhering to standard dental instrument protocols. The device is classified as Class II under FDA regulations (21 CFR 872.4120) and has received FDA 510(k) clearance and MDD authorization. Multiple model and reference codes are associated with its regulatory submissions, reflecting variations in design or configurations.
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Questions
AI-generated answers, 18 Sep 2026
What types of dental procedures is the Piezo Bone Surgery System designed to assist with, and how does it differ from traditional rotary drills?
The Piezo Bone Surgery System is specifically designed for dental applications requiring precision bone resection, such as extractions, implant site preparation, and periodontal surgery. Unlike traditional rotary drills, it uses ultrasonic piezoelectric technology to oscillate at high frequencies, minimizing heat generation and reducing collateral damage to surrounding soft tissues and nerves. This makes it ideal for procedures where tissue preservation is critical, such as near critical anatomical structures.
Is the Piezo Bone Surgery System single-use or reusable, and what sterilization process should be followed before use?
The Piezo Bone Surgery System is a reusable medical device. It is not sterile upon receipt and must be sterilized before use following standard dental instrument protocols. The manufacturer recommends adhering to established sterilization methods for dental tools, such as autoclaving or chemical sterilization, to ensure safety and efficacy.
What regulatory pathways has the Piezo Bone Surgery System undergone, and what does this mean for its use in clinical settings?
The device has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for safety and effectiveness. The FDA classification under 21 CFR 872.4120 as a Class II device indicates it has undergone substantial equivalence review by the Dental (DE) Advisory Committee. This means it has been deemed comparable to a legally marketed predicate device, ensuring it meets established performance criteria for dental bone surgery applications.
Are there different models or configurations of the Piezo Bone Surgery System, and how can I identify the correct one for my practice?
Yes, the Piezo Bone Surgery System includes multiple model variations, as indicated by the diverse FEI numbers (e.g., 1000160293, 3004975279) and registration numbers listed in the regulatory submissions. These variations may correspond to different handpiece designs, power settings, or accessory attachments. To identify the correct model for your practice, consult the manufacturer’s documentation or contact Guilin Woodpecker Medical Instrument Co., Ltd. for guidance tailored to your specific clinical needs.