# K962741: Tri-Phasix Chromatic Alginate

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 6, 1996 after 53 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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) Chromaclone Color Changing Alginate: named in the summary without a submission number
- (no number) Orthalgenat Impression Material: named in the summary without a submission number
- (no number) Algidenco Impression Material: named in the summary without a submission number
- (no number) Algiprint Impress Material: named in the summary without a submission number
- (no number) Dental Alginate Impression Material: named in the summary without a submission number
- (no number) Proof Alginate Impression Material: named in the summary without a submission number
- (no number) Cutter-Jel Alginate Impression Material: named in the summary without a submission number

## Indications for use
The product is intended for use as impression material as defined in §872.3660 of CFR 21, "to reproduce the structure of a patient’s teeth and gums to provide models for study and for production of restorative prosthetic devices," etc.

Source page: https://510kreport.com/device/K962741
Methodology: https://510kreport.com/methodology