# K883842: Dental Alginate Impression Material W/Anti. Addi.

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 17, 1989 after 186 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.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K952614: Jeltrate Plus Antimicrobial Impr. Material (1996), 13 descendants of its own
- 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

Source page: https://510kreport.com/device/K883842
Methodology: https://510kreport.com/methodology