# K253758: Dental Cone; Dental Sponge

- Pathway: 510(k) (Special)
- Applicant: Medizin Produkte Neustadt GmbH (Mpn)
- Decided: Dec 18, 2025 after 23 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K910944 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133290: Collacare Dental, Innocoll Pharmaceuticals (2014) Summary page 5.

## Indications for use
Indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.

Source page: https://510kreport.com/device/K253758
Methodology: https://510kreport.com/methodology