Cleared Traditional

K222623 - Digital Crown

K222623 is an FDA 510(k) clearance for Digital Crown, manufactured by Sprintray, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K222623 · Sprintray, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
105d
Days
Class 2
Risk

K222623 is an FDA 510(k) clearance for the Digital Crown. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 14, 2022 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sprintray, Inc. devices

FDA 510(k) Submission Details - K222623

510(k) Number K222623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 643
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K222623.
Admira Fusion 5
K230877 · Voco GmbH · Jul 2023
Dental Ceramic Blocks
K223742 · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 2023
LC ChromeFlow
K222445 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Mar 2023
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632 · Premier Dental Products Company · Dec 2022
Stela Automix System
K222581 · Sdi Limited · Oct 2022
Stela Capsule System
K222583 · Sdi Limited · Oct 2022