510(k) · Cleared
ClearedDeka Smartperio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · NVK Laser, Dental, Soft Tissue
Cleared on Mar 11, 2022 as substantially equivalent to K203396 (El.En Electronic Engineering Spa, 2021) after a 112-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Mar 11, 2022
- Review
- 112 days
- Class
- Class II
- Product code
- NVK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030290 (2004). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K203396 | Deka SmartperioSummary page 5…egulatory Class: Class II Classification Number: 21 CFR 878.4810 1 Predicate Device: DEKA SMARTPERIO (K203396) Device Description: The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio s… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 17.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NVK devicesNVK Laser, Dental, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NVK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVK
139in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVK
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVK
1in 2024
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 intraoral 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…
Read the full statement (186 words)
The DEKA SmartPerio system is intended to perform intraoral 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/K213658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213658: Deka Smartperio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213658
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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