FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
K Number: K140278
·
Decision Jun 20, 2014
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
11
Review Days
137
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Basic Information
- Device Name
- SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
- K Number
- K140278
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somnomed, Inc.
- Date Received
- February 3, 2014
- Decision Date
- June 20, 2014
- Product Code
- LRK
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
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Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
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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 |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | May 17, 2013 | Substantially Equivalent |
| K121340 | SOMNODENT G2 | May 30, 2012 | Substantially Equivalent |
| K102909 | SOMNOBRUX SPLINTS | Dec 13, 2011 | Substantially Equivalent |
| K102521 | PANTINO PRO POSITINER | Mar 28, 2011 | Substantially Equivalent |
| K073004 | SOMNOMED BFLEX | Jan 30, 2008 | Substantially Equivalent |