# K251252: NOBILCAM IMPAK Disc

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Aug 1, 2025 after 100 days
- Product code: MQC (Mouthguard, Prescription)
- 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: 1 generation back to K111828 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111828: Clearsplint ES, Astron Dental Corporation (2011) Summary page 5.

## Indications for use
The NOBILCAM IMPAK Disc is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, nightguards, bruxism appliances and other devices as prescribed.

Source page: https://510kreport.com/device/K251252
Methodology: https://510kreport.com/methodology