# K063007: Powertome Periotome

- Pathway: 510(k) (Traditional)
- Applicant: Westport Medical, Inc.
- Decided: Oct 17, 2006 after 15 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Periotome made by B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.: named in the summary without a submission number
- (no number) Periotome made by Osseous Technologies of America: named in the summary without a submission number
- (no number) Periotome made by Karl Schumacher: named in the summary without a submission number
- (no number) Periotome made by others: named in the summary without a submission number

## Indications for use
This device is to be used to expand the tooth socket to facilitate tooth removal, due to caries, trauma, orthodontic reasons, periodontal bone loss, or the malformation of the tooth, and/or to prepare the site for placement of endosseous dental implants or abutments.

Source page: https://510kreport.com/device/K063007
Methodology: https://510kreport.com/methodology