Cleared Special

K213658 - DEKA SMARTPERIO

K213658 is an FDA 510(k) clearance for DEKA SMARTPERIO, manufactured by El.En Electronic Engineering Spa. The device is a Class 2 Dental device with product code NVK cleared through the Special 510(k) pathway after a 112-day FDA review.

K213658 · El.En Electronic Engineering Spa · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
112d
Days
Class 2
Risk

K213658 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, US). The FDA issued a Cleared decision on March 11, 2022 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K213658

510(k) Number K213658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2021
Decision Date March 11, 2022
Days to Decision 112 days
Submission Type Special
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
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

NVK Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K213658.
Solea
K221761 · Convergent Dental, Inc. · Sep 2022
Dental diode laser, SOGA Laser, ILaser II
K211150 · Shenzhen Soga Technology Co., Ltd. · Jul 2022
Dental diode laser
K214008 · Shenzhen Soga Technology Co., Ltd. · May 2022
D-Laser Blue, D-Laser 16
K210367 · Guilin Woodpecker Medical Instrument Co., Ltd. · Mar 2022
EdgePro
K213428 · Biolase, Inc. · Dec 2021
Gemini 2 810+980 Soft Tissue Laser
K210350 · Azena Medical, LLC · Nov 2021
K213658 · DEKA SMARTPERIO
Download PDF FDA Summary El.En Electronic Engi…