# K232087: Dental LT Comfort Resin

- Pathway: 510(k) (Special)
- Applicant: Formlabs Ohio, Inc.
- Decided: Feb 16, 2024 after 218 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: 7 generations back to K924830 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222061: Dental LT Clear V2 Resin, Formlabs Ohio, Inc. (2022) Summary page 5.
- K183598: KeyPrint KeySplint Soft, Keystone Industries (2019) Summary page 5.

## Indications for use
Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

Source page: https://510kreport.com/device/K232087
Methodology: https://510kreport.com/methodology