FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SOMNOBRUX SPLINTS
K Number: K102909
·
Decision Dec 13, 2011
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
11
Review Days
438
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Basic Information
- Device Name
- SOMNOBRUX SPLINTS
- K Number
- K102909
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnomed, Inc.
- Date Received
- October 1, 2010
- Decision Date
- December 13, 2011
- Product Code
- MQC
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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Other Clearances by Somnomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261366 | Virtus | Jun 12, 2026 | Substantially Equivalent |
| K233497 | Rest Assure System | Oct 3, 2024 | Substantially Equivalent |
| K183443 | SomnoDent Avant | May 8, 2019 | Substantially Equivalent |
| K162306 | SomnoDent ALPHA | Sep 20, 2016 | Substantially Equivalent |
| 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 | Jun 18, 2015 | Substantially Equivalent |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | Jun 20, 2014 | Substantially Equivalent |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | May 17, 2013 | Substantially Equivalent |
| K121340 | SOMNODENT G2 | May 30, 2012 | Substantially Equivalent |
| K102521 | PANTINO PRO POSITINER | Mar 28, 2011 | Substantially Equivalent |
| K073004 | SOMNOMED BFLEX | Jan 30, 2008 | Substantially Equivalent |