# K083516: Periogenix

- Pathway: 510(k) (Traditional)
- Applicant: Oroscience, Inc.
- Decided: Feb 20, 2009 after 86 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
Longest line of descent: 2 generations back to K810545 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881422: Coe Pak Auto Mix, Regular or Hard Set, Coe Laboratories, Inc. (1988) Summary page 1.
- K050658: Reso-Pac Periodontal Dressing, Hager Worldwide, Inc. (2005) Summary page 1.

## Most influential descendants
- K251908: Emanate Tray (2026), 0 descendants of its own

## Indications for use
Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.

Source page: https://510kreport.com/device/K083516
Methodology: https://510kreport.com/methodology