# K050658: Reso-Pac Periodontal Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hager Worldwide, Inc.
- Decided: May 27, 2005 after 74 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: 1 generation back to K810545 (1981). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810545: Pca Periocare Periodontal Dressing, Pulpdent Corp. of America (1981) Summary page 1.
- K881422: Coe Pak Auto Mix, Regular or Hard Set, Coe Laboratories, Inc. (1988) Summary page 1.
- K864720: Light-Cured Periodontal Dressing, Dentsply Intl. (1987) Summary page 1.

## Most influential descendants
- 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
- K142130: Oral Bond (2016), 0 descendants of its own

## Indications for use
For use as a periodontal wound dressing to protect injured periodontal tissue by forming a barrier to avoid further irritation.

Source page: https://510kreport.com/device/K050658
Methodology: https://510kreport.com/methodology