FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K150369
·
Decision Jun 18, 2015
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
8
Applicant Total
11
Review Days
125
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Basic Information
- Device Name
- 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
- K Number
- K150369
- 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 13, 2015
- Decision Date
- June 18, 2015
- Product Code
- PLC
- 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 |
|---|---|---|---|
| PLC | Sleep Appliances With Patient Monitoring | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLC), ordered by most recent decision date.
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Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
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Acrylic Herbst Appliance with Micro-Recorder
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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 |
| 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 |
| 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 |