Cleared Traditional

K241283 - Elemental Granulate (FDA 510(k) Clearance)

K241283 · Zinkh NV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
241d
Days
-
Risk

K241283 is an FDA 510(k) clearance for the Elemental Granulate. Classified as Oral Wound Dressing (product code OLR).

Submitted by Zinkh NV (Gent, BE). The FDA issued a Cleared decision on January 3, 2025 after a review of 241 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Zinkh NV devices

Submission Details

510(k) Number K241283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2024
Decision Date January 03, 2025
Days to Decision 241 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
114d slower than avg
Panel avg: 127d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 38
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K241283.
Dental Cone
K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dec 2025
Silatrix Oral Gel
K252425 · Sa3, LLC · Oct 2025
HealiAid Dental Collagen Wound Dressing
K230529 · Maxigen Biotech, Inc. · Nov 2023
PerioStom Dental Dressing
K221428 · Forward Science, LLC · Dec 2022
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021