# K952614: Jeltrate Plus Antimicrobial Impr. Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 13, 1996 after 435 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 K883842 (1989). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883842: Dental Alginate Impression Material W/Anti. Addi., Dentsply Intl. (1989) Summary page 2.

## Most influential descendants
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own
- K180185: Bio-C Repair (2018), 3 descendants of its own
- K102867: Iroot FS (2010), 2 descendants of its own
- K243353: One-Fil Putty (2025), 1 descendant of its own

## Indications for use
JELTRATE PLUS is used for all routine dental impressions.

Source page: https://510kreport.com/device/K952614
Methodology: https://510kreport.com/methodology