Cleared Traditional

K213904 - Kerecis Oral

K213904 is an FDA 510(k) clearance for Kerecis Oral, manufactured by Kerecis. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K213904 · Kerecis · Dental device
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Sep 2022
Decision
290d
Days
Class 2
Risk

K213904 is an FDA 510(k) clearance for the Kerecis Oral. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Kerecis (Isafjordur, IS). The FDA issued a Cleared decision on September 30, 2022 after a review of 290 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 Kerecis devices

FDA 510(k) Submission Details - K213904

510(k) Number K213904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2021
Decision Date September 30, 2022
Days to Decision 290 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
163d slower than avg
Panel avg: 127d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPL Device Classification - Class 2, Special Controls

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
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 - NPL Barrier, Animal Source, Intraoral

All 32
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K213904.
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