Cleared Abbreviated

Dental diode laser (K214008) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K214008 · Shenzhen Soga Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
139d
Days
Class 2
Risk

K214008 is an FDA 510(k) clearance for the Dental diode laser. Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Shenzhen Soga Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 10, 2022 after a review of 139 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shenzhen Soga Technology Co., Ltd. devices

Submission Details

510(k) Number K214008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date May 10, 2022
Days to Decision 139 days
Submission Type Abbreviated
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
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Standards-based clearance path.

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 K214008.
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
K232222 · Medency S.R.L. · Nov 2023
Solea
K221761 · Convergent Dental, Inc. · Sep 2022
Dental diode laser, SOGA Laser, ILaser II
K211150 · Shenzhen Soga Technology Co., Ltd. · Jul 2022
DEKA SMARTPERIO
K213658 · El.En Electronic Engineering Spa · Mar 2022
D-Laser Blue, D-Laser 16
K210367 · Guilin Woodpecker Medical Instrument Co., Ltd. · Mar 2022
EdgePro
K213428 · Biolase, Inc. · Dec 2021