# K974865: CSR

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Mar 16, 1998 after 77 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. The FDA summary names its predicate without a number.
- (no number) Resil: named in the summary without a submission number
- (no number) Acusoft Soft Liner: named in the summary without a submission number
- (no number) Liteline VLC Soft Denture Reline: named in the summary without a submission number
- (no number) Permaflex Permanent Soft Denture Reliner: named in the summary without a submission number
- (no number) Soft Denture Reline Material Elastoline: named in the summary without a submission number
- (no number) Tokuyama Soft Relining: named in the summary without a submission number

## Indications for use
Parkell’s CSR is a self-curing (auto-polymerizing) silicone material that is intended for use by trained and licensed dental professionals as an easy-to-use soft reline material for removable prosthetic appliances, either full or partial, to enhance their fit and comfort.

Source page: https://510kreport.com/device/K974865
Methodology: https://510kreport.com/methodology