# K251626: Midmark Dental Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corporation
- Decided: Nov 3, 2025 after 159 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 K003090 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120239: Elevance, Midmark (2012) Summary page 5.

## Indications for use
Midmark Dental Delivery Systems are intended to provide dental professionals with low voltage electric, air, and water to operate dental handpieces, syringes, and accessories during dental examinations and procedures. Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water, and suction to operate dental handpieces, syringes, and accessories during dental examinations and procedures.

Source page: https://510kreport.com/device/K251626
Methodology: https://510kreport.com/methodology