# K964692: Perfectim

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Feb 25, 1997 after 95 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
Longest line of descent: 1 generation back to K781083 (1978). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930248: Vinyl Polysiloxane 2 Component Vulcanizing System, Crown Delta Corp. (1994) Summary page 2.
- K871409: Vinyl Polysiloxane Impression System, Crown Delta Corp. (1987) Summary page 2.
- K781083: Dental Silicone Impression Material, Crown Delta Corp. (1978) Summary page 2.
- K872745: Vinyl Polysiloxane Impression System, Crown Delta Corp. (1987) Summary page 2.
- K801380: Crown Delta Silicone Impression Material, Crown Delta Corp. (1980) Summary page 2.

## Indications for use
To take dental impressions.

Source page: https://510kreport.com/device/K964692
Methodology: https://510kreport.com/methodology