Cleared Traditional

K222623 - Digital Crown
(FDA 510(k) Clearance)

K222623 · Sprintray, Inc. · Dental
Dec 2022
Decision
105d
Days
Class 2
Risk

K222623 is an FDA 510(k) clearance for the Digital Crown. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 14, 2022, 105 days after receiving the submission on August 31, 2022.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K222623 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2022
Decision Date December 14, 2022
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690