FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K Number: K212706
·
Decision Dec 13, 2021
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
44
Applicant Total
5
Review Days
109
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Basic Information
- Device Name
- SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
- K Number
- K212706
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Splintek, Inc.
- Date Received
- August 26, 2021
- Decision Date
- December 13, 2021
- 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 |
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Other Clearances by Splintek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250122 | SleepRight Snore Aid | May 19, 2025 | Substantially Equivalent |
| K212767 | SleepRight Select-Comfort Dental Guard | Dec 22, 2021 | Substantially Equivalent |
| K193577 | SleepRight ProRx Custom Dental Guard | Jun 1, 2020 | Substantially Equivalent |
| K172223 | SleepRight ProRx Custom Dental Guard | Nov 17, 2017 | Substantially Equivalent |