Cleared Traditional

Stela Capsule System (K222583) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222583 · Sdi Limited · Dental device
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Oct 2022
Decision
63d
Days
Class 2
Risk

K222583 is an FDA 510(k) clearance for the Stela Capsule System. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sdi Limited (Melbourne, AU). The FDA issued a Cleared decision on October 28, 2022 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sdi Limited devices

Submission Details

510(k) Number K222583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2022
Decision Date October 28, 2022
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K222583.
Digital Crown
K222623 · Sprintray, Inc. · Dec 2022
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632 · Premier Dental Products Company · Dec 2022
Stela Automix System
K222581 · Sdi Limited · Oct 2022
TrusFIL-Flow Flowable Composite Restorative
K221510 · Rizhao Huge Biomaterials Company, Ltd. · Oct 2022
Renamel® Microhybrid
K222435 · Cosmedent, Inc. · Oct 2022
DENU Composite Resin, DENU Flow Resin
K213339 · Hdi, Inc. · Sep 2022