FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
REST ASSURED GENERATION III DENTAL PROTECTOR
K Number: K120103
·
Decision Feb 3, 2012
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
8
Review Days
22
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Basic Information
- Device Name
- REST ASSURED GENERATION III DENTAL PROTECTOR
- K Number
- K120103
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ranir, LLC
- Date Received
- January 12, 2012
- Decision Date
- February 3, 2012
- 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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Other Clearances by Ranir, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR | Dec 20, 2013 | Substantially Equivalent |
| K112879 | REST ASSURED READY TO WEAR NITE PROTECTOR | Jan 27, 2012 | Substantially Equivalent |
| K103004 | SNORE GUARD | Feb 25, 2011 | Substantially Equivalent |
| K102118 | SNORE GUARD ADVANCE | Sep 8, 2010 | Substantially Equivalent |
| K094020 | GRIND NO MORE GENERATION II | Jan 25, 2010 | Substantially Equivalent |
| K091175 | GRIND NO MORE VERSION 2 AND 3 | May 8, 2009 | Substantially Equivalent |
| K063229 | REST ASSURED NITE PROTECTOR | Dec 19, 2006 | Substantially Equivalent |