# K222061: Dental LT Clear V2 Resin

- Pathway: 510(k) (Traditional)
- Applicant: Formlabs Ohio, Inc.
- Decided: Nov 10, 2022 after 120 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: 6 generations back to K924830 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203000: KeyPrint KeySplint Hard, Mycone Dental Supply Co. Inc. (Dba Keystone Industries) (2021) Summary page 4.
- K183598: KeyPrint KeySplint Soft, Keystone Industries (2019) Summary page 4.

## Most influential descendants
- K232087: Dental LT Comfort Resin (2024), 0 descendants of its own

## Indications for use
Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

Source page: https://510kreport.com/device/K222061
Methodology: https://510kreport.com/methodology