# K980616: Permafix Chairside Soft Denture Relining (7010) (7011-13) (7014-15)

- Pathway: 510(k) (Traditional)
- Applicant: Kohler Medizintechnik GmbH & Co. KG
- Decided: Apr 30, 1998 after 71 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PERMAFIX is intended to permanently reline a denture surface that contacts tissue. The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-the-counter (OTC) use. Applications To avoid and to relieve pressure areas in the upper and lower denture Post-damming of the A-line Elastic cover for dentures in the upper jaw Cushioning of overdentures that contact implants during the process of healing in the field of implantology Physical Characteristics: The reliner remains permanently soft. Material: A-Silicone

Source page: https://510kreport.com/device/K980616
Methodology: https://510kreport.com/methodology