(82 days)
The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the IMTEC Bone Collector System, primarily focusing on its description, indications for use, materials, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table or details about a study.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.