Virtus— 510(k) K261366
Substantially EquivalentSomnomed, Inc.
FDA 510(k) clearance K261366 for Virtus, Substantially Equivalent on 2026-06-12. Applicant: Somnomed, Inc.. Device class: 2.
Summary
Virtus from Somnomed is filed under LRK, anti-snoring devices. The record doesn't describe the device beyond its name and the code name.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel, and it came in as a Special 510(k).
Somnomed filed from Plano, Texas. The decision came 46 calendar days after FDA received it (April 27 to June 12, 2026).
Clearance details
- Applicant
- Somnomed, Inc.
- Product code
- Product code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plano, TX, US
Recent devices under product code LRK
view allMore clearances from Somnomed, Inc.
view all- K233497 — Rest Assure System
- K183443 — SomnoDent Avant
- K162306 — SomnoDent ALPHA
- K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
- K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
Adverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.