Cleared Traditional

DenMat Glutaraldehyde Desensitizer (K222357) - FDA 510(k) Clearance

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

K222357 · Denmat Holding, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
5d
Days
Class 2
Risk

K222357 is an FDA 510(k) clearance for the DenMat Glutaraldehyde Desensitizer. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Denmat Holding, LLC (Lompoc, US). The FDA issued a Cleared decision on August 9, 2022 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Denmat Holding, LLC devices

Submission Details

510(k) Number K222357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2022
Decision Date August 09, 2022
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 121
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K222357.
EZ Bond Universal
K230009 · Meta Biomed Co., Ltd. · Mar 2023
Rainbow 360
K222830 · Kerr Corporation · Jan 2023
Phosphoric Acid Etching Gel
K221450 · Rizhao Huge Biomaterials Company, Ltd. · Sep 2022
UniPrime A, UniPrime E, UniPrime E/C
K221033 · S&C Polymer Silicon- Und Composite Spezialit?ten GmbH · Jul 2022
Dia-X Bond Universal
K220804 · DiaDent Group International · Jun 2022
Adhese Universal DC, Cention Primer
K210804 · Ivoclar Vivadent, AG · Jun 2022