Cleared Traditional

K221255 - SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

K221255 is an FDA 510(k) clearance for SimpliShade Bulk Fill, manufactured by Kerr Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K221255 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
121d
Days
Class 2
Risk

K221255 is an FDA 510(k) clearance for the SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Corporation (Pomona, US). The FDA issued a Cleared decision on August 31, 2022 after a review of 121 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 Kerr Corporation devices

FDA 510(k) Submission Details - K221255

510(k) Number K221255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date August 31, 2022
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K221255.
DENU Composite Resin, DENU Flow Resin
K213339 · Hdi, Inc. · Sep 2022
FREEPRINT crown
K222877 · Detax GmbH · Sep 2022
AMBARINO High-Class
K222723 · Creamed GmbH & Co. Produktions- Und Handels KG · Sep 2022
G-CAM
K220329 · Graphenano Dental S.L. · Aug 2022
IMICRYL Composite, Composite Flow Materials
K220077 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Aug 2022
J-Temp
K221909 · Ultradent Products, Inc. · Jul 2022