# K881422: Coe Pak Auto Mix, Regular or Hard Set

- Pathway: 510(k) (Traditional)
- Applicant: Coe Laboratories, Inc.
- Decided: Oct 31, 1988 after 209 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K050658: Reso-Pac Periodontal Dressing (2005), 4 descendants of its own
- K083516: Periogenix (2009), 1 descendant of its own
- K071484: Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040 (2007), 1 descendant of its own
- K251908: Emanate Tray (2026), 0 descendants of its own
- K241283: Elemental Granulate (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K881422
Methodology: https://510kreport.com/methodology