FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K Number: K113326
·
Decision Jun 27, 2012
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
2
Review Days
230
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
- K Number
- K113326
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oralabs, Inc.
- Date Received
- November 10, 2011
- Decision Date
- June 27, 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
Other 510(k) clearances with the same product code (OBR), ordered by most recent decision date.
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
FDA 510(k)
FDA Unclassified
·Unknown
Owl Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
enCore Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Remi Custom Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Dentemp Pro-Comfort Dental Guard
FDA 510(k)
FDA Unclassified
·Unknown
Anti Grinding Guard
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Oralabs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray | Nov 21, 2019 | Substantially Equivalent |