FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SleepRight Select-Comfort Dental Guard
K Number: K212767
·
Decision Dec 22, 2021
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
5
Review Days
113
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Basic Information
- Device Name
- SleepRight Select-Comfort Dental Guard
- K Number
- K212767
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Splintek, Inc.
- Date Received
- August 31, 2021
- Decision Date
- December 22, 2021
- Product Code
- MQC
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | 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 |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Dec 13, 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 |