510(k) · Cleared

Cleared

Deka Smartperio

K203396510(k) TraditionalCleared Aug 23, 2021278-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

El.En Electronic Engineering Spa · NVK Laser, Dental, Soft Tissue

Cleared on Aug 23, 2021 as substantially equivalent to K030290 (Millennium Dental Technologies, Inc., 2004) after a 278-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Aug 23, 2021
Review: 278 days
Class: Class II
Product code: NVK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K030290 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK030290 Periolase ND:Yag Dental Laser SystemMillennium Dental Technologies, Inc. · 2004
This deviceK203396 Deka SmartperioEl.En Electronic Engineering Spa · 2021
Descendant · cites it directly · 0 of its ownK213658 Deka SmartperioEl.En Electronic Engineering Spa · 2022

Most influential descendants

Showing 1 of 1 · See all

K213658Deka SmartperioEl.En Electronic Engineering Spa · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030290	Periolase ND:Yag Dental Laser System	Millennium Dental Technologies, Inc.	2004	—
0 (this device)	K203396	Deka Smartperio	El.En Electronic Engineering Spa	2021	—
+1	K213658	Deka Smartperio	El.En Electronic Engineering Spa	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K203396, 2004–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NVK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NVK device

#1 K210367 D-Laser Blue, D-Laser 16score 20.7 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K030290	Periolase ND:Yag Dental Laser System Summary page 5 …surgery and in dermatology Product Code : GEX Classification Number: 21 CFR 878.4810 Equivalent Device: Millennium Dental Technologies, Inc : PerioLase Dental Laser (K030290) (Primary predicate) Device Description: The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The…	Millennium Dental Technologies, Inc.	2004	—

Also cleared against K030290: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K213658	Deka Smartperio	El.En Electronic Engineering Spa	2022	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K213658 (El.En Electronic Engineering Spa, 2022) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K030290.

How does its category compare?

All NVK devices

NVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · NVK

2in 2025

2007high 5 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVK

139in 2022

2007high 277 (2021) · low 139 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NVK

1in 2023

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NVK

1in 2024

2007high 4 (2015) · low 0 (2007)2025

MAUDE reports naming product code NVK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	1	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	4
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	4	277	0	0
2022	5	139	0	0
2023	1	—	1	0
2024	2	—	0	1
2025	2	—	0	0
2026	2	—	0	—

What is it indicated for?

The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage…

Read the full statement (191 words)

The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery.

The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system.

The device is intended to be used in dentistry.

The following are the oropharyngeal indications for use:

Abscess Incision and Drainage

Apthous Ulcers Treatment

Biopsies Excision and Incision

Crown lengthening

Hemostatic assistance

Fibroma Removal

Frenectomy

Frenotomy

Gingival Incision and Excision

Gingivectomy

Gingivoplasty

Operculectomy

Oral Papillectomy

Tissue retraction for Impression

Vestibuloplasty.

Selective ablation of enamel (first degree) caries

Exposure of unerupted / partially erupted teeth

Implant recovery

Lesion (tumor) removal

Leukoplakia

Pulpotomy

Pulpotomy as adjunct to root canal therapy

Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility.

Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K203396 · printed Nov 4, 2026

Cite this page

510(k) Report. “K203396: Deka Smartperio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203396

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026