Cleared Traditional

K203396 - DEKA SMARTPERIO (FDA 510(k) Clearance)

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

K203396 · El.En Electronic Engineering Spa · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
278d
Days
Class 2
Risk

K203396 is an FDA 510(k) clearance for the DEKA SMARTPERIO. Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on August 23, 2021 after a review of 278 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - 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.

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Submission Details

510(k) Number K203396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2020
Decision Date August 23, 2021
Days to Decision 278 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
151d slower than avg
Panel avg: 127d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVK Laser, Dental, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.
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 - NVK Laser, Dental, Soft Tissue

All 15
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K203396.
Gemini NOVA 810+980 Soft Tissue Laser
K260765 · Azena Medical, LLC · Mar 2026
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731 · Matelaser, Inc. · Oct 2025
Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
K243764 · Wuhan Pioon Technology Co., Ltd. · May 2025
Medical Diode Laser Systems
K230047 · Gigaalaser Company , Ltd. · Mar 2024
Dawn Diode Laser System
K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Feb 2024
DEKA SMARTPERIO
K213658 · El.En Electronic Engineering Spa · Mar 2022