SOMNOBRUX SPLINTS— 510(k) K102909
Substantially EquivalentSomnomed, Inc.
FDA 510(k) clearance K102909 for SOMNOBRUX SPLINTS, Substantially Equivalent on 2011-12-13. Applicant: Somnomed, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Somnomed, Inc.
- Product code
- Code MQC
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frisco, TX, US
Recent devices under product code MQC
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view all- K261366 — Virtus
- 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
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
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.