# K973248: Imtec Bone Collector System

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Nov 19, 1997 after 82 days
- Product code: EHZ (Evacuator, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822065 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971036: Odontit Autogenous Bone Collection Device, Interpore Intl. (1997) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K973248
Methodology: https://510kreport.com/methodology