# K222623: Digital Crown

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Dec 14, 2022 after 105 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K042819 (2004). 30 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210977: E-Dent 1000, Envisiontec GmbH (2021) Summary page 4.

## Most influential descendants
- K242277: Crown HT (2024), 1 descendant of its own
- K261246: SRGC-06 (2026), 0 descendants of its own
- K260152: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) (2026), 0 descendants of its own
- K260661: Midas Restore (2026), 0 descendants of its own

## Indications for use
SprintRay Digital Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

Source page: https://510kreport.com/device/K222623
Methodology: https://510kreport.com/methodology