SURGYBONE
by Silfradent S.R.L. Italy 510(k)
510(k) K083569 Product code DZI
Overview
SURGYBONE is a powered bone drill classified as a Class II medical device under FDA regulation 872.4120. It is substantially equivalent to a predicate device and was cleared via the 510(k) pathway with an abbreviated review. The device is intended for dental applications and is manufactured by Silfradent S.R.L.
SURGYBONE is supplied as a non-sterile, reusable device for use in dental clinical settings. It requires cleaning and sterilization by the user prior to each use. The device is not MRI safe unless explicitly stated in labeling, which is not provided in the data. Storage should follow manufacturer guidelines for electrical and mechanical components. Authorizations include FDA 510(k) clearance under K083569.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083569 | Date1 Apr 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
From the manufacturer
Ultrasound bone surgery device Class IIa medical device. Surgybone SB 300 aims at satisfying doctors' everyday need, including the need to exploit room space at best. Thanks to its extreme versatility, selecting the ENDOS programme, the device can be turned into a highly performing ultrasound equipment.
Ultrasound Bone Surgery Device Class IIa medical device. SB 400 Surgybone high power SB 400L Surgybone high power with led light Surgybone aims at satisfying doctors' everyday need, including the need to exploit room space at best. You can choose among twenty free programs, ten of which are preset.
Other devices from Silfradent S.R.L.
Questions
What is SURGYBONE used for?
SURGYBONE is intended for dental applications as a powered bone drill, designed for use in dental clinical settings to perform bone preparation procedures.
Is SURGYBONE sterile when supplied?
SURGYBONE is supplied as a non-sterile device and must be cleaned and sterilized by the user prior to each use to ensure it is safe for clinical application.
Can SURGYBONE be reused?
Yes, SURGYBONE is a reusable device; however, it requires thorough cleaning and sterilization by the user after each use to maintain safety and functionality.
How should SURGYBONE be stored?
SURGYBONE should be stored according to the manufacturer’s guidelines for electrical and mechanical components to preserve its integrity and performance between uses.
What regulatory pathway was used for SURGYBONE?
SURGYBONE received FDA 510(k) clearance under K083569 via an abbreviated review, demonstrating substantial equivalence to a predicate device in the dental drill category.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K083569