FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSTOM COMFORT NIGHTGUARD
K Number: K083400
·
Decision Dec 11, 2008
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
8
Review Days
24
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Basic Information
- Device Name
- CUSTOM COMFORT NIGHTGUARD
- K Number
- K083400
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Den Tek Oral Care, Inc.
- Date Received
- November 17, 2008
- Decision Date
- December 11, 2008
- Product Code
- OBR
- 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 |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Dentemp Pro-Comfort Dental Guard
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Anti Grinding Guard
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Other Clearances by Den Tek Oral Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151149 | Ready-Fit | Sep 30, 2015 | Substantially Equivalent |
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Jul 15, 2013 | Substantially Equivalent |
| K123849 | NEW COMFORT-FIT DENTAL GUARD | Jan 10, 2013 | Substantially Equivalent |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | Jun 12, 2009 | Substantially Equivalent |
| K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | Jul 10, 2008 | Substantially Equivalent |
| K072147 | DEN TEK COMFORT FIT NIGHTGUARD | Aug 30, 2007 | Substantially Equivalent |
| K063483 | DEN TEK NIGHTGUARD | Jan 23, 2007 | Substantially Equivalent |